Ø3.2mm PIN GUIDE, LOCKING 0312-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00848665010664), received between Feb 28, 2022 and Dec 29, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (6 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.

• MalfunctionDec 29, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 08-DEC-2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT WHEN DRILLING A LAG SCREW DURING A HIP FRACTURE SURGERY, THE 0312-200 3.2 MM LOCKING PIN GUIDE COLD-WELDED INTO THE LAG SCREW DRILL GUIDE AND NO LONGER ADVANCED. THIS WAS DISCOVERED DURING THE CASE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23907057 ↗
• MalfunctionDec 8, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 11/18/2025, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN 0312-200 PIN GUIDE WAS INSERTED INTO THE LAG SCREW GUIDE PIN SLEEVE. WHEN ADVANCING AND REDIRECTING FOR PROPER PLACEMENT, THE GUIDE PIN WELDED ITSELF TO THE GUIDE PIN SLEEVE. IT COULD NOT BE REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT HARM. ALSO, THE CAP ON AN 0616-000 OBTURATOR HAD FALLEN OFF OR BECAME UNSTUCK FROM THE OBTURATOR ITSELF. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23743605 ↗
• MalfunctionDec 1, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 11/06/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN 0312-200 PIN GUIDE GOT STUCK INSIDE THE INSERTION SLEEVE AND LOCKED UP. THIS WAS DISCOVERED DURING A TROCH NAIL PROCEDURE. THE CASE WAS COMPLETED WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23679171 ↗
• MalfunctionNov 26, 2025Break; Break

  ON 11/06/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN 0312-200 LOCKING PIN GUIDE BLACK CONNECTION BROKE AND WOULD NOT CLICK INTO THE OUTER SHEATH DUE TO WEAR AND TEAR. THIS WAS DISCOVERED DURING THE CASE. THE SLEEVE WAS PUSHED DOWN ON THE OUTER SLEEVE TO GET ACCURATE MEASUREMENTS, AND THE CASE WAS COMPLETED WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23656880 ↗
• MalfunctionMay 6, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 04/14/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(6) THAT A 0312-200 3.2MM PIN GUIDE, LOCKING ASSEMBLY HAD THE SPRING GETTING STUCK IN THE LOCK AND UNLOCK POSITION. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21972412 ↗
• MalfunctionDec 12, 2024Fitting Problem; Fitting Problem

  ON 11/14/2024 A SALES REPRESENTATIVE REPORTED VIA SEMS-(B)(4) THAT A NEW 0312-200 Ø3.2MM PIN LOCKING GUIDE, WOULD NOT CLICK INTO LAG SCREW SHEATH. LOCKING MECHANISM WAS FAULTY. THE OCCURRED ON 3/18/2024 DURING A CMN FEMUR CASE. NOTHING WAS BROKEN IN THE PATIENT AND NOT PATIENT HARM WAS REPORTED. NO CUSTOMER LETTER WILL BE NEEDED AFTER THE INVESTIGATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20913446 ↗
• MalfunctionAug 12, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 07/16/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-(B)(4) THAT A 1268-100 TARGETING ARM WAS MISALIGNED AND REPEATEDLY MISSED THE LAG SCREW. AND A 0312-200 PIN GUIDE WAS GETTING STUCK IN THE SLEEVE SPRING. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19961219 ↗
• MalfunctionNov 30, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 10/31/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06071680 THAT AN 0312-200 3.2MM PIN GUIDE WELDED INTO PLACE, AND THEY WERE UNABLE TO REMOVE THE PIN FROM THE PIN GUIDE. THIS OCCURRED WHILE PERFORMING A TROCH NAIL PROCEDURE WHEN THE SURGEON ADVANCED THE PIN, IT THEN COLD-WELDED INTO PLACE, AND THEY WERE UNABLE TO REMOVE THE PIN FROM THE PIN GUIDE INTRAOPERATIVELY. THEY WERE ABLE TO COMPLETE THE LAG SOCKET WITH THE LAG HOLE DRILL BIT AND ADVANCE THE LAG SCREW WITHOUT FURTHER INCIDENT. THERE WERE NO PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18242743 ↗
• MalfunctionFeb 28, 2022Break; Disconnection

  ON (B)(6) 2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN 0616-000 OBTURATOR, PIN GUIDE, END CAP HAS DISCONNECTED FROM THE SHAFT. AND AN 0312-200 PIN GUIDE SPRING ATTACHMENT CLAMP THAT CONNECTS THE CLAMP TO THE LAG SCREW SHEATH HAS BROKEN AND CAN NO LONGER BE LOCKED TOGETHER. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6)2022.

  Patient problems: Insufficient Information

  MAUDE report 13621242 ↗