MAUDE Adverse Event Report: SYNTHES GMBH INSERTION HANDLE/ RADIOLUCENT SHORT; NAIL, FIXATION, BONE

Catalog Number	03.043.018
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2025, the impact attachment was placed intraoperatively, and the nail was driven in; subsequently, the impact attachment could no longer be detached from the targeting device.During the inspection, it was identified that it continues to get stuck.There was no allegation against nail.There was a surgical delay.No other medical intervention was required.The procedure was successfully completed.
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 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.H11 additional narrative: added: b5, d9, d10 (concomitant), h4 corrected: d4 (lot, primary udi number) h3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.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
Additional information received states that there was no allegation against the nail.
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: f10.Corrected: h4.H3, h6: the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found signs of normal use, no signs of issues that could lead to the malfunction of the device.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional evaluation was performed several attempts of assemble and disassembly were made, with the mating device driving cap (03.043.028) also returned in this complaint.It was possible to preformed the complete assembly process, no signs of resistance or friction were felt.The assembly process work as expected.The overall complaint was not confirmed as the observed condition of the insert-handle radioluc short would have not 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.Device history review: part number: 03.043.018-15.Lot number: 46736p8.Manufacturing site: hägendorf.Release to warehouse date: 26-feb-2025.A manufacturing record evaluation was performed for the finished device batch number, 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: INSERTION HANDLE/ RADIOLUCENT SHORT
• Common Device Name: NAIL, FIXATION, BONE
• 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 wrights lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 21902758
• Report Number: 8030965-2025-04026
• Device Sequence Number: 15631498
• Product Code: JDS
• UDI-Device Identifier: 07612334170996
• UDI-Public: (01)07612334170996(10)637P080
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K201336
• 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,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: 03.043.018
• Device Lot Number: 637P080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/16/2025
• Supplement Date Received by Manufacturer: 05/12/2025; 06/10/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 05/14/2025; 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/25/2025
• 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: UNK - NAILS
• Patient Sex: Unknown