MAUDE Adverse Event Report: Synthes GmbH REDUCTION FORCEPS WITH SERRATED JAW-RATCHET 144MM

Catalog Number	399.99
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the connector screw is loose.
Additional Manufacturer Narrative
Product complaint # (b)(4) 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional narrative: h3, h6: investigation summary the product was returned to depuy synthes for evaluation.Visual inspection of the returned device found the weld from the connector pin was broken.Due to breakage the ratcheting mechanism does not work as intended as the handle is loose.The observed condition of the device was consistent with a component failure that was caused by exposure to unintended forces.Properly handling and attention to the approved use of the device diminishes the risk of failure.A dimensional inspection was unable to be performed due to the post-manufacturing damage.The overall complaint was confirmed as the observed condition of the red forceps serrated jaw-ratchet 144 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 proposed.There is no indication that a design or manufacturing issue has caused the reported 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: 399.99 lot: a7ga05 product code: n/a date of manufacture: week 05, 1997 manufacturing location: tuttlingen part expiration date: n/a nonconformance noted: n/a a manufacturing records evaluation is not possible, the dhr is no longer available due to the age of the instrument (over 29 years old).Therefore the exact date of manufacture is unknown.

• Brand Name: REDUCTION FORCEPS WITH SERRATED JAW-RATCHET 144MM
• 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 wright lane east; west chester, PA 19380 ; +1(908)386-3534
• MDR Report Key: 50857561
• Report Number: 8030965-2026-09642
• Device Sequence Number: 13136035
• Product Code: HTD
• UDI-Device Identifier: 10886982203175
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• 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: A7 GA 05
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/27/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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