MAUDE Adverse Event Report: SYNTHES GMBH INSERT-HANDLE HYBRID; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	03.037.011
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported during a tfna procedure on (b)(6) 2026, the surgeon could not get the nail off the aiming arm.No further information is known at this time.
Event or Problem Description
Additional information received: a.Kindly re-confirm what is the timing of the reported event? (pre-op, intra-op, post-op) -post- op.
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: b5, d10 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.Corrected: g1.H3, h6: the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that insert-handle hybrid was received in assemble condition withthe mating screw and nail.No cosmetic damage was idenfitied on the surface.A dimensional inspection for the insert-handle hybrid was not performed as it is not applicable to the complaint condition.A functional test was performed to attempt disassemble the devices and the test failed, the devices were stuck.The complaint condition was replicated and due to it was not possible to disassemble the devices, a root cause for this failure mode cannot be established.Per the tfn-advanced proximal femoral nailing system (tfna) - screw only surgical technique guide se_847003 rev.Af the following inforation is relevant.Insert nail assemble the hexagonal screwdriver with spherical head to the connecting screw until it clicks into the recess.Match the geometry of the handle to the nail and connect the nail to the insertion handle.The nail will click in and self retain.Pass the connecting screw through the insertion handle and securely tighten with the hexagonal screwdriver with spherical head.To verify the appropriate position of the locking mechanism for the screw, pass the 5.0 mm flexible screwdriver through the cannulated connecting screw and turn counter-clockwise until it stops.Remove the hexagonal screwdriver.Precautions: ensure that the connection between the nail and the insertion handle is tight (retighten if necessary).Do not attach the aiming arm to the insertion handle yet.If a 235 mm or longer nail is selected, reconfirm that the correct nail (right or left) is assembled.The overall complaint was confirmed as the observed condition of the insert-handle hybrid 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 depuy synthes 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.Dimensional inspection: n/a.Device history lot = > product code: 03.037.011.Lot number: l840506.Release to warehouse date : 03.Oct.2018.Expiration date : na.Supplier: na.Manufacturing site: werk hagendrof.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: INSERT-HANDLE HYBRID
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HAEGENDORF; im bifang 6; haegendorf CO ; SZ
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 24146430
• Report Number: 8030965-2026-00735
• Device Sequence Number: 9210424
• Product Code: HSB
• UDI-Device Identifier: 07611819642379
• UDI-Public: (01)07611819642379(10)L840506
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K131548
• 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: 03.037.011
• Device Lot Number: L840506
• 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: 01/08/2026
• Supplement Date Received by Manufacturer: 02/03/2026; 02/03/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 02/04/2026; 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TFNA FEM NAIL Ø12 LE 130° L300 TIMO15.; UNK - GUIDES/SLEEVES/AIMING: AIMING ARM.; UNK - SCREWS: CANNULATED.
• Patient Sex: Unknown