Arthrex® AR-3602Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00888867206946), received between Sep 14, 2017 and Jan 14, 2026 — classified as 6 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 16, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• 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 24070679 ↗
• 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 24070383 ↗
• MalfunctionAug 29, 2025Break; Break

  IT WAS REPORTED THAT AFTER A SURGERY, THE POST-OPERATIVE X-RAY SHOWED A DRILL TIP STILL REMAINING IN THE PATIENT, WHICH WASN¿T REALISED DURING THE OPERATION. AN ADDITIONAL SURGERY HAS BEEN PLANNED TO REMOVE THE BROKEN DRILL TIP ON (B)(6) 2025. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. UPDATE (B)(6) 20-AUG: FURTHER INFORMATION WAS RECEIVED THAT THE ORIGINALLY ALLEGED DEVICE IS INCORRECT. THE ALLEGED DEVICE IS AR-3602. DESCRIPTION REMAINS THE SAME: TIP BROKE DURING A LATARJET PROCEDURE AND THAT WAS DISCOVERED POST-OPERATIVELY WITH X-RAY. REVISION SURGERY HAS BEEN PERFORMED ON (B)(6).

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

  MAUDE report 22924139 ↗
• MalfunctionMar 19, 2025Break; Break

  ON 3/5/2025, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT AN AR-3602 FIBERTAK TIP BROKE UPON INSERTION INTO THE PATIENT'S SHOULDER. TWO PIECES FROM THE BROKEN TIP WERE RETRIEVED. THE PIECES WERE COMPARED TO AN IDENTICAL IMPLANT SHOWING IDENTICAL SIZE AND LENGTH. AN X-RAY CONFIRMED THAT NO FOREIGN BODY WAS RETAINED. THE SURGERY WAS COMPLETED WITH A NEW FIBERTAK. THIS WAS DISCOVERED DURING A RIGHT SHOULDER ARTHROSCOPY, LABRAL REPAIR VS DEBRIDEMENT, POSSIBLE BICEPS TENODESIS, POSSIBLE OPEN SURGERY PROCEDURE IN (B)(6) 2025.

  Patient problems: Insufficient Information

  MAUDE report 21644350 ↗
• MalfunctionJun 3, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED DURING A SHOULDER REPAIR THE FIBERTAK WOULD NOT DEPLOY. IT WAS REPLACED WITH ANOTHER ANCHOR AND THE CASE WAS COMPLETED WITH NO FURTHER ISSUES. TO DATE, THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19449036 ↗
• MalfunctionJun 1, 2024Defective Device; Defective Device

  IT WAS REPORTED ON 12/02/2022 BY A ARTHREX EMPLOYEE VIA SEMS THAT AN AR-3602 FIBERTAPE HAD A "RED FIBROUS MATERIAL COMING OUT OF THE ANCHOR AFTER ANCHOR INSERTION". CASE INVOLVEMENT, NO PATIENT EFFECT. PER FACILITY: "PRODUCT SURVEILLANCE COMMENTED THAT THEY COULD NOT CONFIRM THE REPORT.I WOULD LIKE TO REPORT IT AGAIN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19444342 ↗
• MalfunctionMay 10, 2024Break; Break

  ON 11/9/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3602 FIBERTAK INSERTED TIP BROKE INSIDE THE PATIENT AFTER THE SUTURE ANCHOR WAS IMPLANTED. THIS WAS DISCOVERED DURING A LABRAL REPAIR ON (B)(6) 2021. SURGEON WAS ABLE TO RETRIEVE ALL BROKEN FRAGMENTS FROM INSIDE THE PATIENT, FLUSHED THE AREA, AND THE FIBERTAK SUTURE ANCHOR REMAINED IN PLACE SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 19288407 ↗
• MalfunctionApr 23, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 03/27/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3602 FIBERTAK ANCHOR PULLED OUT MULTIPLE TIMES. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19162857 ↗
• MalfunctionJan 16, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A TENDON REFIXATION TWO ANCHORS WITH THE SAME LOT NUMBER DID NOT HOLD. THE THIRD ONE WITH A DIFFERENT LOT NUMBER HELD. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 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 18519112 ↗
• MalfunctionJan 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A TENDON REFIXATION TWO ANCHORS WITH THE SAME LOT NUMBER DID NOT HOLD. THE THIRD ONE WITH A DIFFERENT LOT NUMBER HELD. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 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 18510612 ↗
• MalfunctionJan 5, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 11/10/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT (2) AR-3602 FIBERTAK SUTURE ANCHOR PULLED OUT AND FRAYED THE SUTURES. THIS WAS DISCOVERED DURING A SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2022. BOTH ANCHORS WERE REMOVED COMPLETELY AND NEW AR-3602 FIBERTAK SUTURE ANCHOR WERE USED TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 18453815 ↗
• MalfunctionJul 3, 2023Break; Break

  ON 06/06/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3602 FIBERTAK INSERTER BROKE OFF IN THE PATIENT'S BONE. THIS WAS DISCOVERED DURING A SIX-MONTH POST-OPERATIVE VISIT. THE PROCEDURE WAS A GLENOID INSTABILITY REPAIR, AND IT WAS PERFORMED IN (B)(6) 2022. NO FURTHER INFORMATION HAS BEEN PROVIDED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17247610 ↗
• InjuryJun 13, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-3602 FIBERTAK SUTURE ANCHOR WAS FOUND BROKEN VIA X-RAY, DURING A THREE WEEK POST OPERATIVE VISIT. PATIENT UNDERWENT A SUBPEC BICEP TENODESIS PROCEDURE ON (B)(6) 2022, WHICH WAS COMPLETED SUCCESSFULLY AND NO ISSUES WERE REPORTED. HOWEVER, ON (B)(6) 2022, SURGEON NOTICED THE FIBERTAK HAD BROKEN AND A REVISION SURGERY HAS BEEN SCHEDULE FOR (B)(6) 2022. NO FURTHER INFORMATION HAS BEEN GIVEN AS OF TODAY. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022: THE 20MM FIBERTAK INSERTER PIECE CAME OUT WITHOUT INCIDENT, AND IN ONE PIECE. THE ANCHOR HELD THE TENODESIS AS WELL. ADDITIONAL INFORMATION RECEIVED (B)(6) 2022: REVISION PROCEDURE TOOK PLACE ON 5/16/2022 AT THE SAME FACILITY AS THE ORIGINAL PROCEDURE AND PERFORMED BY THE SAME SURGEON. NOTHING WAS EXPLANTED DURING REVISION SURGERY AS THE FIBERTAK ANCHOR WAS STILL HOLDING ON TO THE TENODESIS. CASE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUES.

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

  MAUDE report 14674660 ↗
• MalfunctionJun 7, 2022Break; Material Split, Cut or Torn

  ON (B)(6) 2022, PATIENT HAD SHOULDER SURGERY FOR A SHOULDER SLAP TEAR. ON (B)(6) COMPLAINT OF PAIN IN AN ANTERIOR ASPECT, ON X-RAY THERE WAS AN INCIDENTAL FINDING OF A BROKEN INSERTER TIP STILL IN THE SHOULDER NOT NEAR AREA OF PAIN. ON (B)(6) 2022 REMOVAL OF 1.5 MM BROKEN PIECE OF INSTRUMENTATION WAS REMOVED. THE PIECE WAS NOT NOTED BROKEN DURING ORIGINAL SURGERY ON (B)(6) 2022. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Pain

  MAUDE report 14632607 ↗
• MalfunctionOct 12, 2021Break

  ON (B)(6) 2021, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT AN AR-3602 FIBERTAK TIP BROKE. THIS WAS DISCOVERED DURING A SHOULDER INSTABILITY PROCEDURE. AFTER SURGEON INSERTED SUTURE ANCHOR IN BONE HE NOTICED SOMETHING WAS WRONG, HE SLIGHTLY PULLED BACK THE GUIDE AND NOTICED THE TIP OF THE INSERTION HANDLE WAS BROKEN. THE BROKEN TIP WAS REMOVED AND THE SUTURE ANCHOR WAS FIRMLY SET IN THE BONE. CASE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12616758 ↗
• InjuryNov 23, 2020Material Fragmentation

  IT WAS REPORTED THAT DURING AN (B)(6) 2020 EXTENSIVE INTERIOR ANTERIOR AND POSTERIOR LABRAL REPAIR PROCEDURE IN A PATIENT'S RIGHT SHOULDER, THE FOLLOWING OCCURRED: AN AR-3602 FIBERTAK WITH 1.3MM SUTURETAPE WAS INSERTED INTO THE SHOULDER, ACCORDING TO PROPER TECHNIQUE, USING A TIGHT CURVE DRILL GUIDE AND THE APPROPRIATE DRILL BIT. THE ANCHOR WAS PLACED AT THE 4 O'CLOCK POSITION ON THE GLENOID. AFTER DRILLING THE SOCKET, THE SURGEON MAINTAINED THE PROPER POSITION FOR THE DRILL GUIDE, WHILE THE ASSISTANT INSERTED THE ANCHOR INTO THE DRILL GUIDE AND PROCEEDED TO MALLET THE ANCHOR INTO THE SOCKET UNTIL THE PISTON OF THE INSERTER WAS FLUSH WITH THE BACK OF THE DRILL GUIDE. NO UNUSUAL OCCURRENCES OR ABNORMALITIES WERE NOTICED AS THE ANCHOR WAS BEING PLACED. THE ANCHOR WAS THEN PASSED, TIED AND CUT IN THE USUAL FASHION. NO ABNORMALITIES WERE NOTED AT THE TIME. THE SURGERY WAS COMPLETED AND THE PATIENT WAS SENT HOME UNTIL THEIR TWO WEEK FOLLOW-UP APPOINTMENT. DURING THE FOLLOW UP X-RAYS WERE TAKEN AND IT WAS DISCOVERED THAT APPROXIMATELY 6MM OF THE AR-3602 ANCHOR INSERTER TIP WAS RETAINED IN THE GLENOID OF THE PATIENT. THIS WAS REPORTED TO THE ARTHREX SALES REP (B)(6) 2020. IT IS UNKNOWN IF

  Patient problems: Foreign Body In Patient

  MAUDE report 10884504 ↗
• InjuryDec 27, 2017Break; Detachment Of Device Component; Difficult to Remove; Physical Resistance

  IT WAS REPORTED THAT DURING A BANKHART PROCEDURE, THE SURGEON DRILLED THE GLENOID USING A CURVED GUIDE AND A 1.7 DRILL. WHEN HE WENT TO INSERT THE DOUBLE LOADED FIBERTAK (LOT: 10149849, LINE 216678), THE SURGEON WAS EXPERIENCING RESISTANCE. HE THEN MALLETED THE ANCHOR AND THE ANCHOR DID NOT ENGAGE IN THE PRE-DRILLED HOLE, INSTEAD IT MADE ITS OWN PATH. THE SURGEON ATTEMPTED TO REMOVE THE ANCHOR BUT WAS UNSUCCESSFUL AND IN HIS ATTEMPT, THE METAL TIP OF THE FIBERTAK INSERTER BROKE OFF INTO THE GLENOID. THE METAL TIP WAS UNABLE TO BE REMOVED AS WELL. THE CASE WAS COMPLETED WITH A SINGLE LOADED FIBERTAK INSTEAD WITH NO FURTHER INCIDENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7147511 ↗
• InjurySep 14, 2017Positioning Problem

  IT WAS ORIGINALLY REPORTED THAT DURING A DISLOCATION SURGERY, THE SURGEON USED 5 DEVICES. AFTER THE CASE WAS COMPLETED, AN X-RAY WAS TAKEN AND IT WAS FOUND THAT ABOUT 20MM OF THE TIP OF THE FIBERTAK DOUBLE LOADED SUTURETAP ANCHOR DRIVER REMAINED IN THE PATIENT'S BONE. THE SURGEON DID NOT FEEL ANY RESISTANCE WHEN USING THE DEVICES. CURRENTLY, THE SURGEON IS NOT CONSIDERING ANY ADDITIONAL MEASURES. FOLLOW-UP INVESTIGATION:ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2017: DUE TO A POSSIBILITY THAT THE UNRETRIEVED FRAGMENT COULD MOVE WAS OBSERVED, THE SURGEON CARRIED OUT A SECOND SURGERY TO REMOVE THE FRAGMENT ON (B)(6) 2017.

  Patient problems: No Code Available

  MAUDE report 6865380 ↗