MAUDE Adverse Event Report: SYNTHES GMBH PERCUT-ARM F/COLLIN REDUC CLAMP; FORCEPS

Catalog Number	398.754
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H11: additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
Event or Problem Description
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.
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: added: d10.H3, h6: photo investigation the product was not returned to depuy synthes; however, photos were provided for review.The provided evidence was not sufficient to confirm the reported event of unable to assemble/disassemble.Functionality issues cannot be evaluated through a photo investigation.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was not confirmed as the observed condition of the percut-arm f/collin reduc clamp would not contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes 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.Device history lot the device lot number is unknown; therefore, a device history review could not be performed.If the lot/serial number becomes available, the record will be reassessed.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: added: d4 lot, d9, e1 email.Corrected: d4 primary udi number.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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: added: h4.Corrected: g1.H6 component codes: most relevant component code is g07002 (appropriate term/code not available) to capture no findings available due to no product returned.H3, h6: photo investigation the product was not returned to depuy synthes, however photos were provided for review.The provided evidence was not sufficient to confirm the reported event of unable to assemble/disassemble.Functionality issues cannot be evaluated through a photo investigation.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was not confirmed as the observed condition of the percut-arm f/collin reduc clamp would not contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes 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.Device history lot: part: 398.752.Lot: 08.8723.Manufacturing site: werk selzach.Supplier: (b)(4).Release to warehouse date: 01 sep 2008.Expiration date: na.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Note: dhr information was retrieved from pi-16986910258388955 as it is the same lot number.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: h3, h6: the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that percut-arm f/collin reduc clamp was received in assembled condition with the maiting collinear reduction clamp sliding mechan.In additon, wear on the surface due to repetitive use was observed and the release button is missing.The observed condition was identified as an end of life indicator; damage consistent with repeated use and servicing.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.A dimensional inspection for the percut-arm f/collin reduc clamp was not performed as the relevant features of the device were inaccessible.A functional test was performed press the relese plate, the fed rod was push back and the trigger was squeezed and was noted the fed rod advance correctly, however to attemp dissasemble the devices, the release botton from the arm is missing and rotation of the arm to disengage the notch is not posible, therefore the device remains stuck and disassembling them was not possible.A potential reason for this condition can be traced to a possible damage of the internal components of the mechanism.However, due to the inability to access these internal components without damaging the device, this remains unknown, and the complete potential cause not established.Missing components: this 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.The overall complaint was confirmed as the observed condition of the percut-arm f/collin reduc clamp would contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.There is no indication that a design or manufacturing issue has caused the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: part: 398.752.Lot: 08.8723.Manufacturing site: werk selzach.Supplier: (b)(4).Release to warehouse date: 01 sep 2008.Expiration date: na.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Note: dhr information was retrieved from pi-16986910258388955 as it is the same lot number.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PERCUT-ARM F/COLLIN REDUC CLAMP
• Common Device Name: FORCEPS
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 4434 ; SZ 4434
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 24569161
• Report Number: 8030965-2026-02423
• Device Sequence Number: 18518384
• Product Code: HTD
• UDI-Device Identifier: 10886982201584
• UDI-Public: (01)10886982201584(10)08.8723
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,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: 398.754
• Device Lot Number: 08.8723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2026
• Supplement Date Received by Manufacturer: 03/23/2026; 04/07/2026; 04/16/2026; 04/17/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 03/25/2026; 04/08/2026; 04/17/2026; 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2008
• 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
• Concomitant Medical Products and Therapy/Usage Dates: COLLINEAR REDUCTION CLAMP SLIDING MECHAN
• Patient Sex: Unknown