Arthrex® AR-1995SHNRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888867025684), received between Oct 4, 2017 and Aug 15, 2025 — classified as 3 injuries, 6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 15, 2025Break; Break

  ON 07/30/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-1995SHN SCREWDRIVER TIP OF THE POST SCREW BROKE OFF WHEN TRYING TO REMOVE IT, BUT IT WAS RETRIEVED SAFELY AND THERE IS NOTHING LEFT INSIDE THE BODY. THE SCREW WAS ALSO SUCCESSFULLY REMOVED USING A DIFFERENT DRIVER. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22815194 ↗
• MalfunctionJul 22, 2024Break; Break

  ON 07/09/2024, A SALES REPRESENTATIVE REPORTED VIA SEMS- (B)(4) THAT AN AR-1995SHN NONCANNULATED SHORT SCREWDRIVER SHAFT, 2.5 MM HEX, WHEN USED, HAD THE TIP TWISTED AND PARTIALLY BROKEN WHEN THE BI-CORTICAL POST WAS BEING INSERTED. NO PIECES FELL INSIDE THE PATIENT, BUT THE DRIVER WAS UNUSABLE. ANOTHER DRIVER WAS PULLED FROM A DIFFERENT SET TO COMPLETE THE PROCEDURE. THIS WAS DISCOVERED DURING AN ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 7/11/2024: THERE WAS NO CASE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19793377 ↗
• MalfunctionSep 15, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA SEMS THAT AN AR-1995SHN NONCANNULATED SHORT SCREWDRIVER SHAFT HAD AN ISSUE. THE TIP OF THE SHAFT BROKE WHILE REMOVING THE POST SCREW FROM THE KNEE. THE BROKEN FRAGMENT COULD NOT BE REMOVED. THIS OCCURRED DURING USE IN AN UNSPECIFIED PROCEDURE ON (B)(6) 2023 WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON (B)(6) 2023, THE ARTHREX EMPLOYEE PROVIDED THE FOLLOWING INFORMATION VIA EMAIL: THIS OCCURRED DURING AN ACL RECONSTRUCTION PROCEDURE. THE TIP OF THE SHAFT BROKE INSIDE THE PATIENT'S KNEE, AND THE FRAGMENT COULD NOT BE REMOVED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WAS NO CASE DELAY REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17754387 ↗
• MalfunctionDec 7, 2022Break

  IT WAS REPORTED ON 11/21/2022 BY A ARTHREX EMPLOYEE VIA SEMS THAT AN AR-1995SHN SCREWDRIVER TIP BROKE OFF WHILE REMOVING POST SCREW. CASE INVOLVEMENT, DEVICE BROKE DURING USE. ALL FRAGMENTS REMOVED FROM PATIENT, PROCEDURE COMPLETED SUCCESSFULLY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15931053 ↗
• MalfunctionOct 4, 2022Entrapment of Device; Difficult to Remove

  ON (B)(6) 2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA SEMS THAT AN AR-1995SHN DRIVER BROKE AFTER SCREW INSERTION DURING AN ACL RECONSTRUCTION. THE BROKEN PIECE OF THE DRIVER WAS RETAINED WITHIN THE SCREW AND COULD NOT BE REMOVED. ADEQUATE FIXATION WAS ACHIEVED WITH NO CHANGE IN SURGICAL TECHNIQUE OR ADDITIONAL PRODUCT NEEDED.

  Patient problems: Insufficient Information

  MAUDE report 15535243 ↗
• MalfunctionFeb 7, 2022Break; Difficult to Remove

  ON 01/20/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-1995SHN WAS USED IN IMPLANT REMOVAL SURGERY AFTER ACL RECONSTRUCTION ON (B)(6) 2021. WHEN THE SCREW WAS REMOVED, THE PRODUCT WAS BROKEN, AND THE BROKEN PIECE FELL OFF INSIDE THE SCREW. THE BROKEN PIECE AND THE SCREW COULD NOT BE REMOVED AND THE SURGERY WAS COMPLETED WITH THE SCREW LEFT IN THE BODY.

  Patient problems: Foreign Body In Patient

  MAUDE report 13472179 ↗
• InjuryApr 10, 2019Break; Material Twisted/Bent

  IT WAS REPORTED UPON INSERTING THE DISTAL SCREW FOR THE GRAFT DURING A PCL PROCEDURE, A QUANTITY OF THREE AR-1995SHN, NONCANNULATED SHORT SCREWDRIVER SHAFT TIPS TWISTED. THE THREE DRIVERS WERE ALL FROM LOT: 10193571. THE FACILITY REPORTER STATED THAT THE TIP OF THE THIRD AR-1995SHN BROKE OFF INTO THE HEAD OF THE SCREW (PART NUMBER UNKNOWN). THE BROKEN DRIVER TIP WAS FLUSH WITH THE HEAD OF THE SCREW AND REMAINS IMPLANTED IN THE PATIENT. THE FACILITY REPORTER STATED THAT THERE WERE NO ATTEMPTS MADE TO REMOVE THE SCREW AS THE SCREW WAS FULLY PURCHASED AND IMPLANTED. THE CASE WAS COMPLETED WITHOUT FURTHER INCIDENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8500582 ↗
• InjuryOct 23, 2018Break; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN OPERATION TO REMOVE A SCREW THAT WAS IMPLANTED 10 YEARS AGO. THE SURGEON WAS USING HEX NON-CANNULATED SCREWDRIVER, AR-1995SHN. AS THE SURGEON TURNED THE DRIVER, THE TIP OF THE DRIVER BECAME DAMAGED AND BROKE OFF INSIDE THE HEAD OF THE SCREW. THE TIP WAS UNABLE TO BE RETRIEVED AND THE SURGEON ENDED THE OPERATION. NO FURTHER DETAILS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION PROVIDED ON 10/3/2018: THE SURGERY WAS ABORTED AND THE SCREW WAS LEFT IN. THE REPORTER HAS NO INFORMATION AS TO IF OR WHEN THE SURGERY WILL BE SCHEDULED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7994480 ↗
• InjuryOct 4, 2017Break

  IT WAS REPORTED THAT THE PATIENT REINJURED HER ACL AND REQUIRED A REVISION. DURING THE REVISION THE SURGEON ATTEMPTED TO REMOVE AN ARTHREX SCREW (PART NUMBER UNKNOWN) AND THE TIP OF THE SCREW DRIVE BROKE OFF IN THE HEAD OF THE SCREW. THE SCREW WAS NOT IN A PLACE WHERE IT WOULD INTERFERE WITH THE REVISION SO IT WAS LEFT ALONG WITH THE TIP OF THE DRIVER. THE SURGEON IMPLANTED AN AR-1588BTB TO COMPLETE THE REVISION WITH NO FURTHER ISSUES OTHER THAN A SLIGHT DELAY IN THE CASE.

  Patient problems: Device Embedded In Tissue or Plaque; Injury

  MAUDE report 6913256 ↗