MAUDE Adverse Event Report: SYNTHES GMBH SOCKET WRENCH WITH L-HANDLE FOR 12PT NUTS

Catalog Number	388.584
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2025
Type of Reportable Event	Malfunction
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.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: part: 388.584 lot: 1l95408 release to warehouse date: 03 july 2019 manufacturing site: werk hägendorf a manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found the expansion insert deformed at the tip.The star-shaped catch was unable to assemble with the l-handle.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 socket-wrench f/12point nut w/l-handle would 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 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.The drawings reflecting the current and manufactured revisions were reviewed.
Event or Problem Description
It was reported that there was an issue with some instruments.Both instruments on the kit were unusable - one was missing a screw that holds instrument together and one was misaligned so would not hold the sleeve correctly.A socket wrench hsdu must have dismantled the instrument and not been assembled correctly and was missing the vital springs to ensure this can work and tighten the nuts.There was no impact to the patients and delayed surgery for around ten minutes until another set was available.

• Brand Name: SOCKET WRENCH WITH L-HANDLE FOR 12PT NUTS
• Common Device Name: WRENCH
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 21911582
• Report Number: 8030965-2025-04079
• Device Sequence Number: 7266818
• Product Code: HXC
• UDI-Device Identifier: 07611819128767
• UDI-Public: (01)07611819128767(10)1L95408
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,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: 388.584
• Device Lot Number: 1L95408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2019
• 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