NA 314.291Recalls & reported problems

Summary

The FDA's MAUDE database contains 177 adverse event reports that list this exact device (DI 10886982188779), received between Dec 16, 2016 and Sep 21, 2026 — classified as 4 injuries, 173 malfunctions.

The most frequently reported specific device problem is “Break” (137 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 177 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50848678 ↗
• MalfunctionSep 18, 2026Break

  It was reported on (b)(6) 2026, during the procedure, a curved plate was used, which was molded to the anatomy of the patient. Subsequently, the reduction was initiated using the different clamps available in the system. During this process, the specialist asked for the colineal clamp, However, this did not allow the reduction completely, so I showed the specialist the longest arm available for the clamp.Once the long arm is mounted, we begin to make the reduction. At a certain moment, while the specialist was activating the clamp, it broke. Immediately, the clamp was released and the procedure continued using the other reduction options available in the system. Images showed the fragment was removed. No surgical delay. No patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50816970 ↗
• MalfunctionSep 14, 2026Break

  It was reported that the handle of our collinear reduction clamp, has completely broken off. There was no patient harm and no surgical delay reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50756007 ↗
• MalfunctionMay 19, 2026Break; Mechanical Problem

  IT WAS REPORTED BY THE REP THAT THE TRIGGER PART ON THE SLIDING MECHANISM WAS NOT WORKING. THERE WERE NO FRAGMENTS INVOLVED. SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25222164 ↗
• MalfunctionMay 5, 2026Break

  IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. DURING THE SURGERY, A HANDLE PART OF THE CLAMP IN QUESTION BROKE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25086198 ↗
• MalfunctionApr 6, 2026Break

  IT WAS REPORTED THAT ON (B)(6) 2026 THAT HANDLE OF COLINEAR CLAMP BROKE INTRA-OP, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24788745 ↗
• MalfunctionMar 25, 2026Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THE COLLINEAR CLAMP WAS STUCK AND DID NOT ADVANCE. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24691872 ↗
• MalfunctionMar 11, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE TWO PIECES OF THE CLAMP WERE ASSEMBLED AND ARE NOW STUCK TOGETHER AND CANNOT BE DISSEMBLED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24569115 ↗
• MalfunctionFeb 26, 2026Break

  IT WAS REPORTED THAT ON (B)(6) 2026, SLIDE MECHANISM IN COLLINEAR CLAMP WAS BROKEN, CAUSING CLAMP TO NOT FUNCTION PROPERLY. THERE WAS NO SURGICAL DELAY. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24454037 ↗
• MalfunctionFeb 6, 2026Break

  IT WAS REPORTED THAT THE HANDLE OF THE SLIDING MECHANISM BROKE AS SURGEON WAS ENGAGING/ TIGHTENING THE MECHANISM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24280815 ↗
• MalfunctionJan 30, 2026Break

  IT WAS REPORTED THAT THE COLLINEAR REDUCTION CLAMP HANDLE BROKEN AND REALIZED AFTER A SURGERY WHILE TRYING TO PUT THE TRAY BACK TOGETHER. THERE WAS NO SURGICAL DELAY AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24225820 ↗
• MalfunctionJan 22, 2026Break

  IT WAS REPORTED THAT DURING AN ORTHOPEDIC PROCEDURE, THE INSERT-HANDLE, DEPTH GAUGE F/SCR Ø2+2.4 MEAS-RANGE UP-T, AND COLLINEAR REDUCTION CLAMP SLIDING MECHAN WERE INVOLVED IN A REPORTED EVENT. THE EVENT INVOLVED A DAMAGED HANDLE THAT COULD NOT GUARANTEE STERILITY, A BROKEN DEPTH GAUGE, AND A BROKEN HANDLE OF A CLAMP. THERE WAS NO REPORTED CONSEQUENCE OR IMPACT TO THE PATIENT, AND NO SIGNS, SYMPTOMS, OR PATIENT INVOLVEMENT WERE IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24148625 ↗
• MalfunctionJan 9, 2026Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT WHEN VALIDATING THE EQUIPMENT BEFORE SENDING IT TO THE INSTITUTION AND WHEN MOUNTING THE COLLINEAR GRIPPER, IT WAS OBSERVED THAT THE HOOK PRESENTS RESISTANCE WHEN MOUNTED; ONCE MOUNTED, IT IS NOT POSSIBLE TO SEPARATE IT FROM THE CLAMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24019787 ↗
• MalfunctionDec 23, 2025Break; Break

  IT WAS REPORTED THAT THERE WAS A BROKEN HANDLE ON A COLINEAR CLAMP. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23881391 ↗
• MalfunctionDec 16, 2025Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE THAT THE COLLINEAR CLAMP HANDLE BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23822032 ↗
• MalfunctionDec 5, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN ORIF WITH THE PRODUCT IN CASE. APPARENTLY, THE HANDLE OF THE PRODUCT BROKE DURING SURGERY. THE SALES REP RECEIVED THIS INFORMATION THROUGH THE DISTRIBUTOR. THERE WAS NO IMPACT ON THE PATIENT, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23727664 ↗
• MalfunctionSep 3, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON SQUEEZED THE HANDLE AND IT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22954768 ↗
• MalfunctionJul 16, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT COLLINEAR WILL NOT TIGHTEN DOWN. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22521253 ↗
• MalfunctionJul 15, 2025Use of Device Problem; Device-Device Incompatibility; Use of Device Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT DOCTOR WAS USING COLLINEAR CLAMP TO REDUCE A FEMUR FRACTURE ON WEDNESDAY 5/18. DOCTOR REMARKED THE COLLINEAR CLAMP WAS NOT MAINTAINING REDUCTION, THE FEED ROD CONTINUED SLIPPING. DOCTOR DISCONTINUED USING THE COLLINEAR CLAMP AFTER APPROXIMATELY FIVE MINUTES AND SWITCHED TO LARGE BONE FORCEPS FOR REDUCTION. PATIENT OUTCOME WAS GOOD, ESTIMATED DELAY OF CASE WAS FIVE MINUTES. ON 5/20, USER FOUND THE COLLINEAR CLAMP INSTRUMENT SET DOWN IN THE STERILE PROCESSING DEPARTMENT. USER NOTICED THAT THE RELEASE LEVER WAS MISSING. USER CALLED DOCTOR TO ASK ABOUT THE COLLINEAR CLAMP MALFUNCTIONING, ESTIMATED CASE DELAY, AND PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22509016 ↗
• MalfunctionJun 25, 2025Break; Break

  IT WAS REPORTED THAT THE COLLINEAR REDUCTION CLAMP ON THE SHELF WAS BROKEN. THE TEAM NOTICED THAT THE HANDLE WAS BROKEN WHILE ASSEMBLING THE COLLINEAR CLAMP ON THE BACK TABLE AT THE BEGINNING OF A CASE. THE INSTRUMENT WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22331446 ↗
• MalfunctionJun 25, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE A COLLINEAR CLAMP BROKE DURING INTRA OP. NOT SURE WHAT HAPPENED BUT THE HANDLE BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22329717 ↗
• MalfunctionJun 16, 2025Break; Break

  PRODUCT CODE 314.291 WAS USED IN A CASE AND THE BLACK HANDLE BROKE DURING USE. THE SURGERY WAS NOT DELAYED AND IT WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22212666 ↗
• MalfunctionMay 30, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A PPFX HUMERUS FRACTURE, TRIED TO USE A CABLE TENSIONER BUT A 1.0 WOULD NOT PASS THROUGH THE GUN NOR THE ACTUAL INSERT. ADDITIONALLY, COLLINEAR CLAMP DOESN¿T CLAMP, SD DEPTH GAUGES DON¿T SLIDE WELL. SD HAND DRIVERS ARE WARPED, PLATE BENDERS ARE BENT. SURGERY WAS NOT DELAYED DUE TO THE EVENT, AND THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22112930 ↗
• MalfunctionMay 30, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A PPFX HUMERUS FRACTURE, TRIED TO USE A CABLE TENSIONER BUT A 1.0 WOULD NOT PASS THROUGH THE GUN NOR THE ACTUAL INSERT. ADDITIONALLY, COLLINEAR CLAMP DOESN¿T CLAMP, SD DEPTH GAUGES DON¿T SLIDE WELL. SD HAND DRIVERS ARE WARPED, PLATE BENDERS ARE BENT. SURGERY WAS NOT DELAYED DUE TO THE EVENT, AND THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22112926 ↗
• MalfunctionApr 29, 2025Break; Break

  IT WAS REPORTED THAT THE COLLINEAR CLAMP SLIDING MECHANISM BROKE UNDERNEATH THE TRIGGER HANDLE UPON INSPECTION OF THE CLAMP FOR PROCESSING. THERE WAS NO PATIENT INVOLVEMENT WHEN FOUND THROUGH THE INSPECTION. SPD SUPERVISOR FOUND DURING THE INSPECTION PHASE WHILE IN PROCESS OF BEING WRAPPED FOR STERILIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21928013 ↗