Arthrex® AR-1927BCF-3Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00888867023369), received between Sep 6, 2017 and Apr 9, 2026 — classified as 12 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Break” (24 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 9, 2026Break

  ON 19-MAR-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-1927BCF-3 BIOCOMPOSITE CORKSCREW FT TRIPLEPLAY 5.5 MM ANCHOR BROKE DURING INSERTION. THE IMPLANT WAS PLACED INTO THE PATIENT¿S SHOULDER DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2026, AND THE SURGEON OBSERVED THE SCREW BREAKING BEFORE IT HAD FULLY ENGAGED THE BONE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24832693 ↗
• MalfunctionFeb 24, 2026Positioning Failure

  ADDITIONAL INFORMATION: THIS WAS DISCOVERED DURING AN RCR PROCEDURE. THE CASE WAS COMPLETED USING AN AR-1927BCF-65 BIOCOMPOSITE CORKSCREW FT. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED DURING OR FOLLOWING THE PROCEDURE DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24433811 ↗
• MalfunctionAug 15, 2025Break; Break

  ON 7/30/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1927BCF-3 BIOCOMPOSITE CORKSCREW FAILED. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 08/05/2025: DURING A ROTATOR CUFF REPAIR WITH CUFFMEND AUGMENTATION ON (B)(6) 2025, AN AR-1927BCF-3 BIOCOMPOSITE CORKSCREW ANCHOR WAS IMPLANTED IN THE MEDIAL ROW. WHILE TYING KNOTS, THE SURGEON FELT A ¿POP¿ AND NOTICED THE FIXATION HAD LOOSENED. INVESTIGATION REVEALED THE ANCHOR WAS STILL INTACT IN THE BONE, BUT THE SUTURE HAD PULLED OUT OF THE ANCHOR. NO EXCESSIVE FORCE OR UNUSUAL ACTIVITY OCCURRED DURING IMPLANTATION. THE ANCHOR WAS REMOVED USING THE SPENT INSERTER. IT APPEARED THAT AN INTERNAL COMPONENT HAD BROKEN. AFTER INSPECTING THE JOINT SPACE, NO FRAGMENTS WERE FOUND. A SECOND AR-1927BCF-3 ANCHOR FROM THE SAME LOT WAS IMPLANTED INTO THE ORIGINAL HOLE AND FUNCTIONED AS INTENDED. THE CASE WAS DELAYED FOR LESS THAN 10 MINUTES TO REMOVE THE FAILED ANCHOR AND IMPLANT THE SECOND, REQUIRING MINIMAL ADDITIONAL ANESTHESIA. NO PHOTOS WERE TAKEN. ADDITIONAL INFORMATION WAS RECEIVED ON 08/12/2025: THE ORIGINAL IMPLANT BONE SOCKET WAS PREPARED BY USING THE STANDARD, SILVER 5.5 C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22814364 ↗
• MalfunctionJul 15, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THE DEVICE BROKE DURING INSERTION. THE ANCHOR REMAINED IN THE PATIENT BECAUSE THERE WAS STILL ENOUGH GRIP. THE BROKEN FRAGMENTS WERE RETRIEVED. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22512079 ↗
• MalfunctionDec 6, 2024Break; Break

  ON 11/11/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1927BCF-3 BIOCOMPOSITE CORKSCREW FT SUTURE ANCHOR, WHEN INSERTED, WAS NOTICED THAT THE TAILS WERE CUT FROM THE ANCHOR. ALL SUTURES TO ANCHOR WERE REMOVED. THEN, ANOTHER AR-1927BCF-3 BIOCOMPOSITE CORKSCREW FT SUTURE ANCHOR WAS INSERTED AND BROKE INTO TWO PIECES DURING THE INSERTION. ALL TWO PIECES OF THE CORKSCREW AND ALL SUTURES WERE REMOVED FROM THE PATIENT. THE CASE WAS COMPLETED WITH ANOTHER AR-1927BCF-3 BIOCOMPOSITE CORKSCREW FT SUTURE ANCHOR FROM A DIFFERENT LOT WITH NO ISSUES. THE CASE WAS DELAYED 20 MINUTES DUE TO THE ISSUE. THIS WAS DISCOVERED DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.

  Patient problems: Foreign Body In Patient

  MAUDE report 20864754 ↗
• MalfunctionDec 6, 2024Break; Break

  ON 11/11/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1927BCF-3 BIOCOMPOSITE CORKSCREW FT SUTURE ANCHOR, WHEN INSERTED, WAS NOTICED THAT THE TAILS WERE CUT FROM THE ANCHOR. ALL SUTURES TO ANCHOR WERE REMOVED. THEN, ANOTHER AR-1927BCF-3 BIOCOMPOSITE CORKSCREW FT SUTURE ANCHOR WAS INSERTED AND BROKE INTO TWO PIECES DURING THE INSERTION. ALL TWO PIECES OF THE CORKSCREW AND ALL SUTURES WERE REMOVED FROM THE PATIENT. THE CASE WAS COMPLETED WITH ANOTHER AR-1927BCF-3 BIOCOMPOSITE CORKSCREW FT SUTURE ANCHOR FROM A DIFFERENT LOT WITH NO ISSUES. THE CASE WAS DELAYED 20 MINUTES DUE TO THE ISSUE. THIS WAS DISCOVERED DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.

  Patient problems: Foreign Body In Patient

  MAUDE report 20864499 ↗
• MalfunctionOct 29, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE DEVICE BROKE INSIDE THE PATIENT. ALL FRAGMENTS WERE REMOVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 20559028 ↗
• MalfunctionOct 29, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE DEVICE BROKE INSIDE THE PATIENT. ALL FRAGMENTS WERE REMOVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 20558982 ↗
• MalfunctionMar 4, 2024Break; Break

  ON 02/15/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT AN AR-1927BCF-3 BIOCOMPOSITE CORKSCREW FT TRIPLEPLAY ANCHOR SHEARED OFF AND BROKE WHEN IT WAS ABOUT HALFWAY INTO THE BONE SOCKET. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2024. ALL THE BROKEN FRAGMENTS WERE REMOVED FROM INSIDE THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 18826298 ↗
• MalfunctionMar 4, 2024Break; Break

  ON 02/15/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT AN AR-1927BCF-3 BIOCOMPOSITE CORKSCREW FT TRIPLEPLAY ANCHOR SHEARED OFF AND BROKE WHEN IT WAS ABOUT HALFWAY INTO THE BONE SOCKET. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2024. ALL THE BROKEN FRAGMENTS WERE REMOVED FROM INSIDE THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 18826201 ↗
• MalfunctionJan 29, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED ON 1/28/2024: THIS WAS DISCOVERED DURING A ARCR PROCEDURE ON (B)(6) 2024. THE BROKEN FRAGMENTS WERE REMOVED FROM THE PATIENT. THERE WAS A SLIGHT DELAY WITH NO ADDITIONAL ANESTHESIA ADMINISTERED. THERE WERE NO REPORTS OF NEGATIVE EFFECTS ON THE PATIENT DUE TO THE ANCHOR BREAKAGE.

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

  MAUDE report 18594707 ↗
• MalfunctionJan 4, 2024Break; Break

  ON 12/7/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1927BCF-3 5.5 MM BIOCOMPOSITE CORKSCREW FT TRIPLEPLAY DISTAL TIP BROKE DURING INSERTION. AS THE SURGEON TWISTED THE ANCHOR TO DEPLOY IT, A SOUND WAS HEARD AND IMMEDIATELY TWISTED BACK TO REMOVE THE ANCHOR. MOST OF THE ANCHOR WAS INTACT EXCEPT FOR THE DISTAL TIP, WHICH HAD BROKEN OFF IN ONE PIECE AND STAYED IN THE BONE WITH THE SUTURES STILL THREADED THROUGH IT. THE SURGEON TRIED TO PULL ON THE SUTURES TO REMOVE IT, BUT IT WOULDN'T PULL OUT. THE SURGEON CUT THE SUTURES FLUSH TO THE CORTEX, AND THE BROKEN TIP CAME OUT LATER IN THE PROCEDURE WHILE PUNCHING FOR THE NEXT ANCHOR. THE LOOSE FRAGMENTS WERE RETRIEVED FROM THE JOINT. THE CASE WAS COMPLETED USING A NEW ANCHOR WITH A DIFFERENT LOT NUMBER, AND THE PATIENT WAS NOT HARMED. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18444966 ↗
• MalfunctionAug 31, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1927BCF-3 BIOCOMPOSITE CORKSCREWS SUTURES SNAPPED OFF. THIS OCCURRED DURING A ROTATOR CUFF REPAIR ON (B)(6) 2023, AFTER IMPLANTING THE ANCHOR THE SUTURE EYELET SNAPPED RELEASING ALL SUTURES FROM THE IMPLANT. THE IMPLANT REMAINED IN THE PATIENT SECURED, IN ADDITION, ANOTHER AR-1927BCF-3 WAS USED. THE PATIENT HAD A MODERATE BONE THAT WAS PREPPED USING A BLUE PUNCH SILVER PUNCH AND BLUE TAP.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 17662497 ↗
• MalfunctionAug 31, 2023Break; Break

  ON 08/02/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1927BCF-3 BIOCOMPOSITE CORKSCREWS SUTURES SNAPPED OFF. THIS OCCURRED DURING A ROTATOR CUFF REPAIR ON (B)(6) 2023, AFTER IMPLANTING THE ANCHOR THE SUTURE EYELET SNAPPED RELEASING ALL SUTURES FROM THE IMPLANT. THE IMPLANT REMAINED IN THE PATIENT SECURED, IN ADDITION, ANOTHER AR-1927BCF-3 WAS USED. THE PATIENT HAD A MODERATE BONE THAT WAS PREPPED USING A BLUE PUNCH SILVER PUNCH AND BLUE TAP.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 17662396 ↗
• MalfunctionAug 1, 2023Break; Break

  ON(B)(6)2023, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A NURSE REPORTED THAT AN AR-1927BCF-3 BIOCOMPOSITE CORKSCREW FT TRIPLEPLAY ANCHOR BROKE IN HALF. THE SURGEON WAS ONLY ABLE TO RETRIEVE ONE-HALF OF THE BROKEN SCREW, THE OTHER PORTION REMAINED IN THE PATIENT. THIS WAS DISCOVERED DURING A PROCEDURE ON(B)(6)/2023. NO FURTHER INFORMATION WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17439142 ↗
• MalfunctionMar 21, 2023Break; Break

  ON 3/3/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1927BCF-3 BIOCOMPOSITE CORKSCREW® FT TRIPLEPLAY ANCHOR BROKE UPON INSERTION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 16582271 ↗
• MalfunctionNov 7, 2022Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE CORKSCREW ANCHOR BROKE DURING INSERTION. ALL BROKEN PIECES WERE RETRIEVED FROM PATIENT. 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 15743359 ↗
• MalfunctionJul 11, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1927BCF-3 BIO-COMPOSITE CORKSCREW ANCHORS BROKE DURING INSERTION. THERE WAS NOT HARM TO THE PATIENT BUT HIS CAUSED AN HOUR DELAY IN THE PROCEDURE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14976703 ↗
• MalfunctionApr 4, 2022Break; Improper or Incorrect Procedure or Method

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-1927BCF-3 5.5 MM BIOCOMPOSITE CORKSCREW HAD AN ISSUE. DURING A PROCEDURE ON (B)(6) 2022, THE SURGEON DRILLED WITH 2.4 DRILL, UPON TESTING ANCHOR IT RELEASED AND DID NOT HOLD. THE WHITE THREADED MATERIAL BROKE. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON (B)(6) 2022, THE SALES REPRESENTATIVE STATED THE FOLLOWING VIA EMAIL: THIS EVENT OCCURRED DURING A QUADS TENDON REPAIR PROCEDURE. THE DEVICE BROKE INSIDE THE PATIENT, BUT ALL FRAGMENTS WERE FOUND. THE CASE WAS COMPLETED WITH A DIFFERENT METHOD, NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED WITH REGARDS TO DESCRIBING THE DIFFERENT METHOD IN MORE DETAIL AND PATIENT OUTCOME TO DATE. ON (B)(6) 2022, THE SALES REPRESENTATIVE STATED THE FOLLOWING VIA PHONE: IT WAS CONFIRMED THAT THE DEVICE BROKE DUE TO USER ERROR AT THE FACILITY. ANOTHER AR-1927BCF-3 5.5 MM BIOCOMPOSITE CORKSCREW, BATCH NUMBER UNKNOWN, WAS USED TO COMPLETE THE PROCEDURE, NO DEVIATION FROM THE INTENDED PROCEDURE TOOK PLACE. THE CASE WAS COMPLETED SUCCESSFULLY WITH NO DELAY AND NO IMPACT TO THE PATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13995024 ↗
• InjuryMar 14, 2022Output Problem

  ON (B)(6) 2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AFTER NORMAL INSERTION OF TRIPLEPLAY ANCHOR AND PASSING 3 LIMBS OF SUTURE THERE WERE NO OBVIOUS PROBLEMS WITH THE AR-1927BCF-3 ANCHOR. THE SURGEON THEN PROCEEDED TO TENSION THE LIMBS IN ORDER TO TIE DOWN THE REPAIR. WHILE THE SURGEON BEGAN TO PULL BOTH LIMBS OF THE BLUE SUTURE THE SALES REP, NOTICED HOW IT WAS PULLING THE TEAR UP SIGNIFICANTLY. BOTH THE SURGEON AND THE SALES REP NOTICED HOW THE BLUE SUTURES WEREN¿T IN THE ANCHOR ANYMORE AND HAD COME FREE FROM THE EYELET. THE SURGEON DID NOT UNLOAD THE ANCHOR. IT POPPED THROUGH THE MATERIAL EYELET. THE SALES REP ASKED HIM TO LIGHTLY PULL THE SOLID WHITES AND THE SAME THING HAPPENED AND ONCE MORE WITH THE STRIPES. THE ANCHOR REMAINED FULLY SEATED IN THE BONE BUT THE EYELET WAS NOT HOLDING ANY OF THE SUTURES NOT ALLOWING US TO USE IT FOR REPAIR. THIS WAS DISCOVERED DURING USE IN A ROTATOR CUFF REPAIR PROCEDURE. ADDITIONAL INFORMATION RECEIVED 02/23/2022. ON (B)(6) 2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AFTER NORMAL INSERTION OF TRIPLEPLAY ANCHOR AND PASSING 3 LIMBS OF SUTURE USING THE AR-1927BCF-3 ANCHOR. THE SURGEON PROCEEDED TO TENSION THE

  MAUDE report 13757294 ↗
• MalfunctionMay 10, 2021Unraveled Material

  IT WAS REPORTED THAT THE ANCHOR STARTED TO UNRAVEL DURING INSERTION. THE SITE HAD BEEN PRE PUNCHED AND TAPPED. THE ANCHOR WAS REMOVED FROM THE PATIENT AND ANOTHER ANCHOR WAS USED TO COMPLETE THE RCR CASE.

  Patient problems: Insufficient Information

  MAUDE report 11802344 ↗
• InjuryJan 18, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IS HAVING SOME ALLERGIC TYPE SYMPTOMS AND THE SURGEON BELIEVES IT COULD BE RELATED TO THE BIO-COMPOSITE MATERIAL OF THE PATIENT'S AR-1927BCF-3 AND AR-2324BCC IMPLANTS. ADDITIONAL INFORMATION OBTAINED 1/11/21: THE CASE WAS PERFORMED OVER 4 YEARS AGO. IT WAS A SUPRASPINATUS REPAIR. SALES REPRESENTATIVE HAS REQUESTED ADDITIONAL INFORMATION FROM THE SURGEON WHO HAS YET TO PROVIDE A RESPONSE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 11186418 ↗
• InjuryOct 28, 2020Break

  IT WAS REPORTED THAT DURING A (B)(6) 2020 ROTATOR CUFF REPAIR (SUPRASPINATUS TEAR) PROCEDURE THREE AR-1927BCF-3, BIO-COMPOSITE CORKSCREW ANCHORS (LOT 11436533), BROKE ON INSERTION. THE TOP HALF OF THE IMPLANTS BROKE WHILE ANCHORING TO THE HUMERUS. ALL THREE ANCHORS WEE FROM THE SAME LOT/BOX. A PORTION OF TWO OF THE ANCHORS WERE PULLED FROM THE PATIENT. THE DISTAL PORTIONS REMAINED IN THE PATIENT. NO NEW ANCHORS WERE PLACED OVER THE EXISTING ANCHORS. ONE OF THE ANCHORS THAT BROKE ON THE LAST FEW TURNS OF CORKSCREW AND THE SURGEON LEFT THAT ENTIRE ANCHOR IN THE PATIENT AS IT WAS NOT PROUD, BUT RATHER FLUSH IN THE HUMERAL HEAD. NO ADDITIONAL OR LARGER INCISIONS WERE NEEDED AND THE SURGEON DID NOT HAVE TO CHANGE HIS PLANNED TECHNIQUE. THE SURGEON CONTINUED ON TO COMPLETE THE SUTURE BRIDGE. THE PORTIONS OF ANCHORS THAT WERE RETRIEVED WERE DISCARDED AT THE TIME OF PROCEDURE. THE REMAINING TWO ANCHORS FROM THE SAME LOT/BOX WILL BE RETURNED TO USE FOR EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10746278 ↗
• InjuryOct 6, 2020Break; Material Integrity Problem

  IT WAS REPORTED THAT DURING A (B)(6) 2020 ROTATOR CUFF REPAIR PROCEDURE AN AR-1927BCF-3 WAS BEING INSERTED AND THE SUTURE HAD ISSUE AND THE ANCHOR BODY BROKE. THE CORRECT PUNCH (AR-1927PB) WAS USED AND THEN TAP (AR-1927CTB) WAS USED. THE SALES REPRESENTATIVE STATES THE SUTURE HAD AN ISSUE BEFORE THE ANCHOR BROKE. A SECOND ANCHOR WAS THEN INSERTED AND AFTER TWO TURNS THAT ANCHOR BROKE AS WELL. THE BONE WAS NOT ABNORMALLY HARD ACCORDING TO THE SURGEON. SINCE THE FIRST TWO ANCHORS OUT OF THE BOX HAD ISSUE THE ENTIRE BOX WAS TAKEN OUT OF CIRCULATION. TO COMPLETE THE PROCEDURE THE SURGEON SWITCHED FROM AN ANCHOR REPAIR TO A SUTURE ONLY REPAIR WHICH WAS REPORTED TO HAVE NOT BEEN IDEAL FOR THE SURGEON. PORTION OF 1 ANCHOR REMAINED IN THE PATIENT. THE SURGEON DID NOT WANT TO DIG IT OUT OF THE BONE. WHAT IS LEFT OF THE TWO OPENED ANCHORS WILL BE RETURNED. IN ADDITION, 3 UNUSED ANCHORS FROM THE OPEN BOX WILL ALSO BE RETURNED.

  Patient problems: Foreign Body In Patient

  MAUDE report 10634245 ↗
• InjuryDec 2, 2019Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT A BIO-COMPOSITE CORKSCREW, AR-1927BCF-3, WAS USED DURING A PROCEDURE. AS THE SURGEON WAS SEWING THE SOFT TISSUE AROUND THE TIBIA, HE INSERTED THE CORKSCREW AND COMPLETED THE CASE WITH NO ISSUE. AFTER THE PROCEDURE, THE SURGEON REALIZED THAT THE DRIVER TIP WAS BROKEN OFF. THE SURGEON TOOK AN X-RAY AND HE FOUND THAT THE BROKEN PIECE WAS STILL IN THE PATIENT. THE SURGEON THOUGHT IT WOULD CAUSE MORE HARM TO DO A SECOND SURGERY, SO THEREFORE A SECOND SURGERY IS NOT PLANNED. ADDITIONAL INFORMATION PROVIDED 11/20/19: SEWING OF SOFT TISSUE AROUND THE TIBIA WAS THE MAIN PURPOSE OF THE SURGERY. THE TIP OF THE DRIVER WAS LODGED IN THE HEAD OF THE ANCHOR.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9396563 ↗