MAUDE Adverse Event Report: SYNTHES GMBH LOCKSCR F/NAILS Ø5 L 64 XL25; SCREW, FIXATION, BONE

Catalog Number	04.045.064TS
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Skin Inflammation/ Irritation (4545)
Date of Event	01/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient with distal femur fracture was treated with retrograde femoral nail on (b)(6) 2025.Patient reported discomfort (pain/tissue irritation) in distal femur in early 2026,.Follow up x-rays show screw back out of distal oblique screws.0mm end cap was used.Revision surgery was performed on (b)(6) 2025.A lateral attachment washer was implanted.All distal im screws were removed and only proximal retained which is the shorter screw.
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: d4: udi: as the catalog/model number was not provided, (01)gtin is not available.
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: d4 (catalog, lot, expiration date, primary udi #) g1, h4.Corrected: d1.H6 component codes: most relevant component code is g07002 (appropriate term/code not available) to capture no findings available due to no product returned.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device history lot: a manufacturing record evaluation was performed for the finished device product code: 04.045.064ts.Lot number: 8847p39.It was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 25 jan 2024.Manufacturing site: jabil grenchen.Expiry date: 01 jan 2029.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: d10.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: LOCKSCR F/NAILS Ø5 L 64 XL25
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK GRENCHEN; solothurnstrasse 186; grenchen ; SZ
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 24183469
• Report Number: 8030965-2026-00901
• Device Sequence Number: 9578816
• Product Code: HWC
• UDI-Device Identifier: 10886982302793
• UDI-Public: (01)10886982302793(17)290101(10)8847P39
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• 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
• Report Date (Section B): 03/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 04.045.064TS
• Device Lot Number: 8847P39
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/12/2026
• Supplement Date Received by Manufacturer: 02/26/2026; 02/26/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 03/04/2026; 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/25/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LOCKING ATTACHMENT WASHER F/RETROGR FEM.; LOCKSCR F/NAILS Ø5 L 40 XL25.; LOCKSCR F/NAILS Ø5 L 76 XL25.; LOCKSCR F/NAILS Ø5 L 80 XL25.; RETROGR FEM NAIL ADV - RFN-ADV Ø11 L400.; RETROGR FEM NAIL ADV - RFN-ADV Ø11 L400.; VA LOCKSCR ø3.5 SELF-TAP L 70 SST.; VA LOCKSCR ø3.5 SELF-TAP L 70 SST.; VA LOCKSCR ø3.5 SELF-TAP L 80 SST.; VA LOCKSCR ø3.5 SELF-TAP L 80 SST.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown