NA 71513331Recalls & reported problems

Summary

The FDA's MAUDE database contains 163 adverse event reports that list this exact device (DI 03596010589064), received between Jan 3, 2020 and Feb 20, 2026 — classified as 5 injuries, 158 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (37 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 25 most recent of 163 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2026Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TRAUMA SURGERY, ONE (1) UNIVERSAL PIN DRIVER BROKE DURING USE; HOWEVER, ALL PIECES WERE ACCOUNTED FOR. THERE WERE NO RETAINED FRAGMENTS INSIDE THE PATIENT, AND NO X-RAY WAS TAKEN. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED; HOWEVER, THERE WAS NOT DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24405259 ↗
• MalfunctionFeb 12, 2026Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE UNIVERSAL PIN DRIVER BROKE UPON IMPACTION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24322211 ↗
• MalfunctionDec 2, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) UNIVERSAL PIN DRIVER BROKE UPON IMPACTION. THE PROCEDURE WAS RESUMED, WITHOUT ANY SURGICAL DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23694365 ↗
• MalfunctionNov 27, 2025Fracture; Mechanics Altered; Fracture; Mechanics Altered

  IT WAS REPORTED THAT DURING A TKA, THE UNIVERSAL PIN DRIVER BROKE DURING IMPACTION. AT THIS TIME, IT IS UNKNOWN IF ANY PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23666019 ↗
• MalfunctionNov 21, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT ONE (1) UNIVERSAL PIN DRIVER BROKE UPON IMPACTION. THE PROCEDURE WAS COMPLETED, AFTER NO DELAY, USING AN EQUIVALENT S+N BACK UP PRODUCT. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23617433 ↗
• MalfunctionNov 14, 2025Break; Break

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE UNIVERSAL PIN DRIVER BROKE UPON IMPACTION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23556450 ↗
• MalfunctionNov 10, 2025Break; Break

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE UNIVERSAL PIN DRIVER BROKE UPON IMPACTION AND IT HAD LOOSE THREADS. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23509661 ↗
• MalfunctionJun 12, 2025Break; Break

  IT WAS REPORTED THAT, DURING TKA, ONE (1) UNIVERSAL PIN DRIVER WAS BROKEN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22195628 ↗
• MalfunctionDec 18, 2023Break; Break

  IT WAS REPORTED THAT, DURING A TKA, THE LOCKING MECHANISM OF TWO (2) UNIVERSAL PIN DRIVER BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18350235 ↗
• MalfunctionDec 18, 2023Break; Break

  IT WAS REPORTED THAT, DURING A TKA, THE LOCKING MECHANISM OF TWO (2) UNIVERSAL PIN DRIVER BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18350216 ↗
• MalfunctionFeb 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA, THE METAL PART OF A UNIVERSAL PIN DRIVER BECAME DETACHED AND A PIN OF A GII POST REF A/P BLK SZ 7 BROKE OFF. BOTH FAILURES OCCURRED WHILE THE INSTRUMENTS WERE HANDLED IN THE SURGICAL SITE. THE BROKEN PIN OF THE GII POST REF A/P BLK SZ 7 WAS RETRIEVED WITH A PAIR OF FORCEPS AND ACCOUNTED FOR AS BEING COMPLETE. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16383463 ↗
• MalfunctionAug 22, 2022Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT THE CAPTURE MECHANISM OF A UNIVERSAL PIN DRIVER GREW LOOSE OVER TIME. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

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

  MAUDE report 15271684 ↗
• MalfunctionAug 22, 2022Break; Break

  IT WAS REPORTED THAT THE UNIVERSAL PIN DRIVER TIP BROKE. AS THIS WAS NOTICED IN A FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15267056 ↗
• MalfunctionJul 19, 2022Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT, A UNIVERSAL PIN DRIVER IS BROKEN. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15059404 ↗
• MalfunctionMay 14, 2022Break; Break

  IT WAS REPORTED THAT THE UNIVERSAL PIN DRIVER WAS FOUND BROKEN. SINCE THIS WAS NOTICED DURING A FIELD INSPECTION, NO CASE WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14403773 ↗
• MalfunctionJan 7, 2022Break; Break

  IT WAS REPORTED THAT, DURING SET UP FOR A TKA SURGERY, THE LOCKING MECHANISM FOR PINS WAS BROKEN ON THE UNIVERSAL PIN DRIVER. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE WITHOUT DELAY. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13192507 ↗
• MalfunctionJan 7, 2022Break; Break

  IT WAS REPORTED THAT A UNIVERSAL PIN DRIVER BROKE. SINCE IT WAS NOTICED DURING A FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13191884 ↗
• MalfunctionDec 10, 2021Break; Break

  IT WAS REPORTED THAT, THE UNIVERSAL PIN DRIVER WAS BROKEN. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12979684 ↗
• MalfunctionNov 24, 2021Break; Break

  IT WAS REPORTED THAT AN UNIVERSAL PIN DRIVER IS NO LONGER HOLDING PINS SECURELY. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT. THE INVESTIGATION FOUND THAT THE SPRING IS BROKEN ON THE UNIVERSAL PIN DRIVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12868201 ↗
• MalfunctionNov 16, 2021Break; Break

  IT WAS REPORTED THAT, DURING SET-UP/INSPECTION OF A TOTAL KNEE ARTHROPLASTY CASE, THE LOCKING MECHANISM OF AN UNIVERSAL PIN DRIVER WAS OBSERVED TO BE BROKEN. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12820276 ↗
• MalfunctionNov 10, 2021Break; Break

  IT WAS REPORTED THAT, A UNIVERSAL PIN DRIVER WAS BROKEN. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12790918 ↗
• MalfunctionNov 9, 2021Break; Break

  IT WAS REPORTED THAT, AN UNIVERSAL PIN DRIVER AND JOURNEY FEM IMPACT BUMPER RT WERE BROKEN. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12778270 ↗
• MalfunctionAug 11, 2021Material Fragmentation; Connection Problem; Material Fragmentation; Connection Problem

  IT WAS REPORTED THAT, DURING A TKA SURGERY, TWO (2) UNIVERSAL PIN DRIVERS FAILED TO HOLD THE PROFIX BONE SPIKES, BOTH CRACKED WHILE THE SURGEON PLACED THE PINS INTO THE A/P BLOCK. PIECES OF THE DEVICES WERE RETRIEVED BUT IT IS UNKNOWN HOW. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM. ALSO, A GENESIS II POSTERIOR STABILIZED CONSTRAINED HOUSING REAMER DOME HAVE BECOME DULL AND DID NOT REAM WELL. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12307366 ↗
• MalfunctionAug 11, 2021Material Fragmentation; Connection Problem; Material Fragmentation; Connection Problem

  IT WAS REPORTED THAT, DURING A TKA SURGERY, TWO (2) UNIVERSAL PIN DRIVERS FAILED TO HOLD THE PROFIX BONE SPIKES, BOTH CRACKED WHILE THE SURGEON PLACED THE PINS INTO THE A/P BLOCK. PIECES OF THE DEVICES WERE RETRIEVED BUT IT IS UNKNOWN HOW. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM. ALSO, A GENESIS II POSTERIOR STABILIZED CONSTRAINED HOUSING REAMER DOME HAVE BECOME DULL AND DID NOT REAM WELL. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12307363 ↗
• MalfunctionJul 13, 2021Break; Break

  IT WAS REPORTED PER THAT THREE (3) UNIVERSAL PIN DRIVERS ARE BROKEN. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12164282 ↗