MAUDE Adverse Event Report: SYNTHES GMBH COLLINEAR REDUCTION CLAMP SLIDING MECHAN; FORCEPS

Catalog Number	314.291
Medical Device Problem Codes	Use of Device Problem (1670); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: investigation summary: the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found release lever was missing from the device.Missing component may compromise the functionality of the collinear reduction clamp sliding mechan and could affect their assemble with mating devices.The surgical technique guide collinear reduction clamp states on page 8 the following instructions for the release lever.To release the clamp, press the release lever and manually retract the feed rod.To remove the clamp after placing a guide wire into the bone through the cannulated feed rod, disconnect the attachment arm from the sliding mechanism.Note: do not squeeze the trigger while pressing the release lever, as this will not allow the feed rod to slide freely.The reported condition may occur during the cleaning/sterilization process.As these procedures are often repeated, there is an increased risk of components going missing.However, without concrete evidence or further information, it is not possible to determine a root cause.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional evaluation was performed using the internal mechanism of the collinear reduction clamp sliding mechan and found no defects on the trigger, however, release lever was missing from the device, therefore, it is reasonable to conclude that it could affect the correct reduction produced at the moment of the event.The overall complaint was confirmed as the observed condition of the collinear reduction clamp sliding mechan would have contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is required.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Dimensional inspection: n/a.Device history: part number: 314.291, lot number: 13-3163, manufacturing location: werk selzach, supplier: (b)(4), release to warehouse date: 27.Sep.2013.The device history record shows this lot of (b)(4) pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: corrected: b3 and g1 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: correction: g3: initial report of 8030965-2025-07152 reported incorrect date in g3, date received by manufacturer.The correct date is 6/20/2025.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: COLLINEAR REDUCTION CLAMP SLIDING MECHAN
• Common Device Name: FORCEPS
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach CO ; SZ
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 22509016
• Report Number: 8030965-2025-07152
• Device Sequence Number: 12945813
• Product Code: HTD
• UDI-Device Identifier: 10886982188779
• UDI-Public: (01)10886982188779(10)13-3163
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 314.291
• Device Lot Number: 13-3163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2025
• Supplement Date Received by Manufacturer: 07/18/2025; 07/18/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 08/15/2025; 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown