MAUDE Adverse Event Report: SYNTHES GMBH RED FORCEPS SERRATED JAW-RATCHET 144

Catalog Number	399.99
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(6).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: h6: photo investigation: the product was not returned to depuy synthes, however photos were provided for review.The photo investigation revealed that red forceps serrated jaw-ratchet 144 , the photographs attached were reviewed, however the image attached doesn't show the complete device and no observations pertaining to the nature of the reported event could be identified.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was not confirmed as the observed condition of the red forceps serrated jaw-ratchet 144 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.H3, h4, h6: device history record (dhr) review conducted: part number: 399.99 lot number: t170330 manufacturing site: (b)(4).Release to warehouse date: 12-sep-2018 a review of the device history records was performed for the finished device lot number and a nc was started because the laser point for screw locking manufactured by the supplier had a crack on 10 from 100 instruments.The defective instruments were scrapped.The necessary actions to ensure the final product quality have been taken and documented in the appropriate quality system.The nc have no impact to the complaint condition.The final quality release criteria were met before this batch was released for distribution.The raw material certificate was reviewed and the used material was according to the specification of the device.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that clamp is broken.The issue was discovered post-operatively.

• Brand Name: RED FORCEPS SERRATED JAW-RATCHET 144
• Common Device Name: FORCEPS
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: elba bello ; 1302 wrights lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 23657571
• Report Number: 8030965-2025-11901
• Device Sequence Number: 4903781
• Product Code: HTD
• UDI-Device Identifier: 10886982203175
• UDI-Public: (01)10886982203175(10)T170330
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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

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: 399.99
• Device Lot Number: T170330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/12/2018
• 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