MAUDE Adverse Event Report: SYNTHES GMBH LCKNG/NEUTRL GUIDE 3.5 VA PRX TIB AM ARM; PLATE, FIXATION, BONE

Catalog Number	03.127.010
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while inspecting the instruments after going through the decontamination process, rep noticed that there were some that were damaged.Rep does not know when this damage occurred whether it was postop or preop.There was no patient involvement.Some of the instruments have to be able to send back, but there are a couple that will not be able to return because they were disposed of by the facility.Rep knows the lot number on some of them, but the ones that were disposed of rep does not know the lot number.1.Product # 314.118, lot # h887026, quantity 1.This item is a t25 screwdriver, and the tip of the screwdriver is stripped.This item is available for return.2.Product # 03.127.010, lot # 8391544, quantity 1.This item is a drill sleeve for an aiming arm, and the tip of it is bent and needs replaced.This item is available for return.3.Product # 319.006, lot # h873105, quantity 1.This item is a depth gauge, and the tip of the depth gauge is broke off.This item is available for return.4.Product.# 03.333.301, lot # unknown, quantity 2.These two items are power shafts t6 and the tips of them were stripped.These items are not available for return due to the facility disposing of them.
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.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: d9, h4.H3, h6: the product was returned to j&j medtech orthopaedics for evaluation.The j&j medtech orthopaedics team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the tip of the lckng/neutrl guide 3.5 va prx tib am arm was found deform/bent.A dimensional inspection for the lckng/neutrl guide 3.5 va prx tib am arm was not performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.The overall complaint was confirmed as the observed condition of the lckng/neutrl guide 3.5 va prx tib am arm 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 j&j medtech orthopaedics 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# 03.127.010.Lot # 8391544.Manufacturing site: werk hagendorf.Manufacturing date: 25 sep 2013.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: LCKNG/NEUTRL GUIDE 3.5 VA PRX TIB AM ARM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 22709621
• Report Number: 8030965-2025-07988
• Device Sequence Number: 13137210
• Product Code: HRS
• UDI-Device Identifier: 10886982075109
• UDI-Public: (01)10886982075109(10)8391544
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K120689
• 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
• Report Date (Section B): 08/04/2025

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: 03.127.010
• Device Lot Number: 8391544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2025
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2013
• 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