Arthrex® AR-2323BCCRecalls & reported problems

Summary

The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 00888867026728), received between Aug 23, 2016 and Sep 25, 2026 — classified as 20 injuries, 49 malfunctions.

The most frequently reported specific device problem is “Break” (39 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 69 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Device Dislodged or Dislocated

  On 10th September 2026, it was reported by an Arthrex's employee via an Email that for 1 unit of AR-2323BCC, Suture Anchor, BioComposite SwiveLock® C, 5.5 mm x 19.1 mm, Closed Eyelet, its anchor pulled out during insertion.This was detected during a rotator cuff repair surgery on (b)(6)2026. The procedure was completed successfully by using another new AR-2323BCC. There were no patient harm and no secondary procedure needed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898489 ↗
• MalfunctionSep 8, 2026Difficult to Insert

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50666464 ↗
• MalfunctionMay 7, 2026Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY THE TIP OF THE DEVICE BROKE WHILE INSERTING THE SUTURE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25114278 ↗
• MalfunctionFeb 6, 2026Break

  ON (B)(6) 2026, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-2323BCC BIOCOMPOSITE SWIVELOCK C SUTURE ANCHOR EXPERIENCED TIP BREAKAGE DURING INSERTION INTO THE BONE HOLE. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT AR-2323BCC BIOCOMPOSITE SWIVELOCK C SUTURE ANCHOR. THERE WAS NO SIGNIFICANT SURGICAL DELAY, AND NO ADDITIONAL ANESTHESIA WAS REQUIRED. THE ISSUE OCCURRED DURING A PROCEDURE ON (B)(6) 2026, AND NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24276812 ↗
• MalfunctionFeb 3, 2026Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY THE DEVICE BROKE DURING INSERTION. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24246944 ↗
• MalfunctionJan 26, 2026Break

  IT WAS REPORTED THAT DURING THE ROTATOR CUFF SURGERY, THE ANCHOR BROKE DURING INSERTION. NO BROKEN PIECES REMAINED IN THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24178475 ↗
• InjuryJan 14, 2026Use of Device Problem

  ON 12/15/2025, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A PATIENT REPORTED UNDERGOING A REVISION BICEPS TENODESIS PROCEDURE ON (B)(6) 2022, OF THE RIGHT SHOULDER DUE TO A HOSPITAL-ACQUIRED SURGICAL SITE INFECTION. THE ORIGINAL TENODESIS WAS REPORTEDLY PERFORMED SOMETIME IN 2022 FOLLOWING INJURIES SUSTAINED IN A MOTOR VEHICLE ACCIDENT. THE PATIENT REPORTED THAT DURING THE REVISION PROCEDURE, THE SURGEON REMOVED THE ORIGINAL SUTURE ATTACHMENT, DEBRIDED THE ANCHOR SITE, AND IMPLANTED THREE NON-ABSORBABLE SUTURE ANCHORS SUBPECTORALLY TO REATTACH THE REMAINING TENDON. THE PATIENT STATED THAT WHILE THE SURGEON WAS INSERTING ONE OF THE ANCHORS, THE DRILL BIT BROKE INSIDE THE ARM, REQUIRING OVER-DRILLING OF THE SITE TO RETRIEVE THE BROKEN FRAGMENT. ACCORDING TO THE PATIENT, THE SURGEON CLAIMED THAT ALL BROKEN PIECES WERE REMOVED. THE PATIENT REPORTS ONGOING INFECTION ISSUES AND PERSISTENT PAIN POST-OPERATIVELY. THE PATIENT FURTHER REPORTED THAT A RECENT OUTSIDE MRI SHOWED A VERY SMALL WHITE SPOT AT THE LOCATION OF ONE OF THE ANCHORS. PER THE PATIENT, THE ANCHORS REMAIN IN PLACE AND ARE VISIBLE ON MRI, AND THE OPERATIVE REPORT NOTES THE USE OF 1.6 MM ANCHORS. NO FURTHER INFORMAT

  Patient problems: Bacterial Infection; Pain

  MAUDE report 24071778 ↗
• MalfunctionDec 31, 2025Break; Break

  ON 11TH DEC 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 2 UNITS OF AR-2323BCC, SUTURE ANCHOR, BIOCOMPOSITE SWIVELOCK® C, 5.5 MM X 19.1 MM, CLOSED EYELET, 1 UNIT OF THE ANCHOR PULLED OUT WHEN RETRIEVING THE POLE. ANOTHER AR-2323BCC WAS CHANGED TO AND ITS ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING THE THIRD AR-2323BCC. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23934860 ↗
• MalfunctionDec 31, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 11TH DEC 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 2 UNITS OF AR-2323BCC, SUTURE ANCHOR, BIOCOMPOSITE SWIVELOCK® C, 5.5 MM X 19.1 MM, CLOSED EYELET, 1 UNIT OF THE ANCHOR PULLED OUT WHEN RETRIEVING THE POLE. ANOTHER AR-2323BCC WAS CHANGED TO AND ITS ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING THE THIRD AR-2323BCC. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23934566 ↗
• MalfunctionNov 20, 2025Break; Break

  ON (B)(6) 2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-2323BCC BIOCOMPOSITE CLOSED-EYELET SWIVELOCK SUTURE ANCHOR BROKE DURING A CASE WITH NO PATIENT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23604306 ↗
• InjuryAug 6, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 07/16/2025, A FACILITY REPRESENTATIVE REPORTED VIA EMAIL THAT ONE OF THEIR PATIENTS DEVELOPED A POST-OPERATIVE INFECTION IN THE LEFT SHOULDER FOLLOWING AN ARTHROSCOPIC PROCEDURE ON (B)(6) 2025. THE FOLLOWING ARTHREX PRODUCTS WERE IMPLANTED DURING THE CASE: (QTY. 2) AR-2324BCCT BIOCOMPOSITE SWIVELOCK C SUTURE ANCHOR. (QTY. 3) AR-2323BCC BIOCOMPOSITE SWIVELOCK C SUTURE ANCHOR. (QTY. 1) AR-2324BCCTT BIOCOMPOSITE SWIVELOCK C SUTURE ANCHOR. (QTY. 1) AR-1680BC BIOCOMPOSITE-TENODESIS SCREW 8 X 12 MM. ABS-3101 BONESYNC FAST-SETTING DRILLABLE CALCIUM PHOSPHATE CEMENT (INJECTION) THE INFECTION WAS IDENTIFIED POST-OPERATIVELY, AND NO ADDITIONAL CLINICAL DETAILS WERE PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON 07/23/2025: THE PATIENT INITIALLY UNDERWENT ROTATOR CUFF REPAIR, BICEPS TENODESIS, AND DISTAL CLAVICLE EXCISION ON (B)(6) 2025. APPROXIMATELY TWO WEEKS AFTER SURGERY, SIGNS OF INFECTION EMERGED, INCLUDING PAIN, TENDERNESS, AND PURULENT DRAINAGE. CLINICAL EVALUATION CONFIRMED A LOCALIZED PURULENT SUBCUTANEOUS ABSCESS, WITH NO EVIDENCE OF INTRA-ARTICULAR INVOLVEMENT AND THE ROTATOR CUFF REMAINING INTACT. A CULTURE COLLECTED DURING ASSESSMENT REVEALED A SCANT AMOUNT OF CUTIBACTERIUM

  Patient problems: Unspecified Infection

  MAUDE report 22725957 ↗
• InjuryAug 6, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 07/16/2025, A FACILITY REPRESENTATIVE REPORTED VIA EMAIL THAT ONE OF THEIR PATIENTS DEVELOPED A POST-OPERATIVE INFECTION IN THE LEFT SHOULDER FOLLOWING AN ARTHROSCOPIC PROCEDURE ON (B)(6) 2025. THE FOLLOWING ARTHREX PRODUCTS WERE IMPLANTED DURING THE CASE: (QTY. 2) AR-2324BCCT BIOCOMPOSITE SWIVELOCK C SUTURE ANCHOR. (QTY. 3) AR-2323BCC BIOCOMPOSITE SWIVELOCK C SUTURE ANCHOR. (QTY. 1) AR-2324BCCTT BIOCOMPOSITE SWIVELOCK C SUTURE ANCHOR. (QTY. 1) AR-1680BC BIOCOMPOSITE-TENODESIS SCREW 8 X 12 MM. ABS-3101 BONESYNC FAST-SETTING DRILLABLE CALCIUM PHOSPHATE CEMENT (INJECTION) THE INFECTION WAS IDENTIFIED POST-OPERATIVELY, AND NO ADDITIONAL CLINICAL DETAILS WERE PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON 07/23/2025: THE PATIENT INITIALLY UNDERWENT ROTATOR CUFF REPAIR, BICEPS TENODESIS, AND DISTAL CLAVICLE EXCISION ON (B)(6) 2025. APPROXIMATELY TWO WEEKS AFTER SURGERY, SIGNS OF INFECTION EMERGED, INCLUDING PAIN, TENDERNESS, AND PURULENT DRAINAGE. CLINICAL EVALUATION CONFIRMED A LOCALIZED PURULENT SUBCUTANEOUS ABSCESS, WITH NO EVIDENCE OF INTRA-ARTICULAR INVOLVEMENT AND THE ROTATOR CUFF REMAINING INTACT. A CULTURE COLLECTED DURING ASSESSMENT REVEALED A SCANT AMOUNT OF CUTIBACTERIUM

  Patient problems: Unspecified Infection

  MAUDE report 22725953 ↗
• InjuryAug 6, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 07/16/2025, A FACILITY REPRESENTATIVE REPORTED VIA EMAIL THAT ONE OF THEIR PATIENTS DEVELOPED A POST-OPERATIVE INFECTION IN THE LEFT SHOULDER FOLLOWING AN ARTHROSCOPIC PROCEDURE ON (B)(6) 2025. THE FOLLOWING ARTHREX PRODUCTS WERE IMPLANTED DURING THE CASE: (QTY. 2) AR-2324BCCT BIOCOMPOSITE SWIVELOCK C SUTURE ANCHOR (QTY. 3) AR-2323BCC BIOCOMPOSITE SWIVELOCK C SUTURE ANCHOR (QTY. 1) AR-2324BCCTT BIOCOMPOSITE SWIVELOCK C SUTURE ANCHOR (QTY. 1) AR-1680BC BIOCOMPOSITE-TENODESIS SCREW 8 X 12 MM ABS-3101 BONESYNC FAST-SETTING DRILLABLE CALCIUM PHOSPHATE CEMENT (INJECTION) THE INFECTION WAS IDENTIFIED POST-OPERATIVELY, AND NO ADDITIONAL CLINICAL DETAILS WERE PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON 07/23/2025: THE PATIENT INITIALLY UNDERWENT ROTATOR CUFF REPAIR, BICEPS TENODESIS, AND DISTAL CLAVICLE EXCISION ON (B)(6) 2025. APPROXIMATELY TWO WEEKS AFTER SURGERY, SIGNS OF INFECTION EMERGED, INCLUDING PAIN, TENDERNESS, AND PURULENT DRAINAGE. CLINICAL EVALUATION CONFIRMED A LOCALIZED PURULENT SUBCUTANEOUS ABSCESS, WITH NO EVIDENCE OF INTRA-ARTICULAR INVOLVEMENT AND THE ROTATOR CUFF REMAINING INTACT. A CULTURE COLLECTED DURING ASSESSMENT REVEALED A SCANT AMOUNT OF CUTIBACTERIUM ACN

  Patient problems: Unspecified Infection

  MAUDE report 22725785 ↗
• InjuryJul 25, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2025, A PATIENT REPORTED VIA PHONE THAT HE EXPERIENCED PAIN AND ONGOING SWELLING OF THE LEFT KNEE AFTER AN MCL RECONSTRUCTION PROCEDURE ON (B)(6) 2024, DURING WHICH AN UNKNOWN 5.5MM SWIVELOCK ANCHOR, AN UNKNOWN FIBERTAK ANCHOR, AND A CADAVERIC MCL LIGAMENT FOR THE GRAFT RECONSTRUCTION WERE IMPLANTED. IT COULD NOT BE CONFIRMED IF THE CADAVERIC MCL LIGAMENT WAS AN ARTHREX PRODUCT. THE PATIENT STARTED TO EXPERIENCE IMMENSE PAIN AFTER THE PROCEDURE AND SWELLING IN THE LEFT LEG AROUND THE KNEE AREA. THE SURGEON PROVIDED PAIN MEDICATION FOR 2 WEEKS. EVEN AFTER 7 MONTHS OF PHYSICAL THERAPY, THE KNEE CONTINUES TO RANDOMLY SWELL. THE PATIENT OBTAINED TWO SECOND OPINIONS AT THE SAME FACILITY AND WAS TOLD THESE SYMPTOMS WERE TO BE EXPECTED. THE PATIENT STATED THAT HE MAY SUE THE DOCTOR AND IS CONTEMPLATING A KNEE REPLACEMENT PROCEDURE. HE EXPERIENCES THE PAIN MOSTLY AROUND THE AREA WHERE THE SWIVELOCK ANCHOR WAS IMPLANTED AT THE TOP OF THE KNEE, NOT WHERE THE FIBERTAK ANCHOR WAS LOCATED AT THE BOTTOM OF THE KNEE. THE PATIENT IS LOOKING FOR THE MATERIAL COMPOSITION OF THE UNKNOWN IMPLANTS AND WILL UNDERGO ORTHOPEDIC ALLERGY TESTING. ON (B)(6) 2025, THE PATIENT PROVIDED THE FOLLOWING

  Patient problems: Pain

  MAUDE report 22608992 ↗
• InjuryJul 25, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2025, A PATIENT REPORTED VIA PHONE THAT HE EXPERIENCED PAIN AND ONGOING SWELLING OF THE LEFT KNEE AFTER AN MCL RECONSTRUCTION PROCEDURE ON (B)(6) 2024, DURING WHICH AN UNKNOWN 5.5MM SWIVELOCK ANCHOR, AN UNKNOWN FIBERTAK ANCHOR, AND A CADAVERIC MCL LIGAMENT FOR THE GRAFT RECONSTRUCTION WERE IMPLANTED. IT COULD NOT BE CONFIRMED IF THE CADAVERIC MCL LIGAMENT WAS AN ARTHREX PRODUCT. THE PATIENT STARTED TO EXPERIENCE IMMENSE PAIN AFTER THE PROCEDURE AND SWELLING IN THE LEFT LEG AROUND THE KNEE AREA. THE SURGEON PROVIDED PAIN MEDICATION FOR 2 WEEKS. EVEN AFTER 7 MONTHS OF PHYSICAL THERAPY, THE KNEE CONTINUES TO RANDOMLY SWELL. THE PATIENT OBTAINED TWO SECOND OPINIONS AT THE SAME FACILITY AND WAS TOLD THESE SYMPTOMS WERE TO BE EXPECTED. THE PATIENT STATED THAT HE MAY SUE THE DOCTOR AND IS CONTEMPLATING A KNEE REPLACEMENT PROCEDURE. HE EXPERIENCES THE PAIN MOSTLY AROUND THE AREA WHERE THE SWIVELOCK ANCHOR WAS IMPLANTED AT THE TOP OF THE KNEE, NOT WHERE THE FIBERTAK ANCHOR WAS LOCATED AT THE BOTTOM OF THE KNEE. THE PATIENT IS LOOKING FOR THE MATERIAL COMPOSITION OF THE UNKNOWN IMPLANTS AND WILL UNDERGO ORTHOPEDIC ALLERGY TESTING. ON (B)(6) 2025, THE PATIENT PROVIDED THE FOLLOWING

  Patient problems: Pain

  MAUDE report 22608953 ↗
• MalfunctionApr 23, 2025Break; Break

  ON 04/10/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-2323BCC SUTURE ANCHOR, BIOCOMPOSITE SWIVELOCK C HAD THE ANCHOR BREAK AT THE TIP DURING INSERTION. THERE WERE NO ISSUES WITH THE EYELET. ALL PIECES WERE RETRIEVED FROM THE PATIENT. THERE WAS NO CASE DELAY OR ADDED ANESTHESIA. THE CASE WAS COMPLETED USING ANOTHER AR-2323BCC SUTURE ANCHOR, BIOCOMPOSITE SWIVELOCK C, FROM THE SAME LOT TO COMPLETE THE CASE. NO ADVERSE EFFECTS ON THE PATIENT. THIS WAS DISCOVERED DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21892123 ↗
• MalfunctionApr 17, 2025Break; Break

  ON 1ST APRIL 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA EMAIL THAT FOR AN AR-2323BCC, SUTURE ANCHOR, BIOCOMPOSITE SWIVELOCK® C, 5.5 MM X 19.1 MM, CLOSED EYELET, THE IMPLANT BROKE DURING INTRAOPERATIVE PERIOD. THIS WAS DETECTED DURING A BICEP TENODESIS PROCEDURE ON (B)(6) 2025. THE CASE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER SWIVELOCK. THERE WAS NO PATIENT HARM. UPDATE ON 2ND APRIL: FRAGMENTS WERE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21857193 ↗
• MalfunctionFeb 12, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED ON 02/07/2025: THIS WAS DISCOVERED DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2025. THE FRAGMENTS WERE RETRIEVED FROM THE PATIENT. AN AR-2323BCC SUTURE ANCHOR, BIOCOMPOSITE SWIVELOCK C WAS USED TO COMPLETE THE CASE. THERE WAS A FIVE-MINUTE CASE DELAY. THERE WAS NO ADDED ANESTHESIA ADMINISTERED TO THE PATIENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21364769 ↗
• MalfunctionFeb 6, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED ON 02/07/2025: THIS WAS DISCOVERED DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2025. THE FRAGMENTS WERE RETRIEVED FROM THE PATIENT. AN AR-2323BCC SUTURE ANCHOR, BIOCOMPOSITE SWIVELOCK C WAS USED TO COMPLETE THE CASE. THERE WAS A FIVE-MINUTE CASE DELAY. THERE WAS NO ADDED ANESTHESIA ADMINISTERED TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 21320906 ↗
• MalfunctionFeb 6, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED ON 02/07/2025: THIS WAS DISCOVERED DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2025. THE FRAGMENTS WERE RETRIEVED FROM THE PATIENT. AN AR-2323BCC SUTURE ANCHOR, BIOCOMPOSITE SWIVELOCK C WAS USED TO COMPLETE THE CASE. THERE WAS A FIVE-MINUTE CASE DELAY. THERE WAS NO ADDED ANESTHESIA ADMINISTERED TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 21320880 ↗
• MalfunctionFeb 3, 2025Break; Break

  ON 01/09/2025, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT AN AR-2323BCC BIOCOMPOSITE SWIVELOCK BROKE. THIS OCCURRED DURING USE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21294498 ↗
• MalfunctionJan 29, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 12/20/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT TWO AR-2324BCC BIOCOMPOSITE SWIVELOCK C WERE IMPLANTED IN A PATIENT. THREE YEARS LATER, ON (B)(6) 2024, THE PATIENT REPORTED SHOULDER WEAKNESS. IMAGES SHOW PARTIAL LOSS OF BONE AROUND THE SWIVELOCK DEVICES. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 1/6/2024: IT WAS CLARIFIED THAT TWO AR-2323BCC BIOCOMPOSITE SWIVELOCK C WERE IMPLANTED AND NOT TWO AR-2324BCC BIOCOMPOSITE SWIVELOCK C. ADDITIONAL INFORMATION RECEIVED ON 1/7/2024: THE ARTHROSCOPIC RCR PROCEDURE TOOK PLACE ON (B)(6) 2021. ALL IMPLANTS REMAIN IN THE PATIENT, AND THERE IS NO REVISION SURGERY SCHEDULED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Osteopenia/ Osteoporosis

  MAUDE report 21266452 ↗
• MalfunctionJan 29, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT TWO AR-2324BCC BIOCOMPOSITE SWIVELOCK C WERE IMPLANTED IN A PATIENT. THREE YEARS LATER, ON (B)(6) 2024, THE PATIENT REPORTED SHOULDER WEAKNESS. IMAGES SHOW PARTIAL LOSS OF BONE AROUND THE SWIVELOCK DEVICES. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 1/6/2024: IT WAS CLARIFIED THAT TWO AR-2323BCC BIOCOMPOSITE SWIVELOCK C WERE IMPLANTED AND NOT TWO AR-2324BCC BIOCOMPOSITE SWIVELOCK C. ADDITIONAL INFORMATION RECEIVED ON 1/7/2024: THE ARTHROSCOPIC RCR PROCEDURE TOOK PLACE ON (B)(6) 2021. ALL IMPLANTS REMAIN IN THE PATIENT, AND THERE IS NO REVISION SURGERY SCHEDULED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Osteopenia/ Osteoporosis

  MAUDE report 21266370 ↗
• InjuryJan 6, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 12/9/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA EMAIL THAT AN AR-2323BCC BIOCOMPOSITE SWIVELOCK WAS IMPLANTED IN A PATIENT ON (B)(6)2024 DURING AN RCR PROCEDURE. THE PATIENT DEVELOPED A POSTOPERATIVE INFECTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 21079820 ↗
• InjuryJan 6, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 12/9/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA EMAIL THAT AN AR-2323BCC BIOCOMPOSITE SWIVELOCK WAS IMPLANTED IN A PATIENT ON (B)(6) 2024 DURING AN RCR PROCEDURE. THE PATIENT DEVELOPED A POSTOPERATIVE INFECTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 21079707 ↗