MAUDE Adverse Event Report: SYNTHES GMBH LOCKSCR Ø5 L38 F/NAILS TAN LIGHT GREEN; SCREW, FIXATION, BONE

Catalog Number	04.005.528
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Unspecified Infection (1930); Unspecified Tissue Injury (4559)
Date of Event	11/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a revision surgery occurred on (b)(6) 2025 due to osteomyelitis.Patient also presented with exposure of the screws in the ankle causing soft tissue injury.The patient remains under management for irrigation and evaluation for possible amputation depending on the evolution of their vascular condition.Date of implant: (b)(6) 2024.Date of explant: (b)(6) 2025.
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.Additional narrative: 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: h3, h6: photo investigation: the product was not returned to depuy synthes, however photos were provided for review.The photo and x-ray investigation revealed a chronological history of the patient, screw in implant and revision date did not presented migration.A screw that was not part of the system was observed as well.The e-ifu trauma instructions for use - tfna states the following: combination of medical devices: synthes has not tested compatibility with devices provided by other manufacturers.As the device was not returned, and as-received condition could not be assessed, a dimensional inspection and document/specification review were not completed.The overall complaint was not confirmed as the observed condition of the lockscr ø5 l38 f/nails tan light green 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 depuy synthes 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 (dhr): lot # provided is not a valid number, therefore, the dhr could not be completed.If device is returned or lot number can be confirmed, the dhr will be revisited.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: LOCKSCR Ø5 L38 F/NAILS TAN LIGHT GREEN
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 23875882
• Report Number: 8030965-2025-12867
• Device Sequence Number: 11954947
• Product Code: HWC
• UDI-Device Identifier: 10886982085962
• UDI-Public: (01)10886982085962(10)L158
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K172157
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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: 04.005.528
• Device Lot Number: L158
• 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: 12/03/2025
• Supplement Date Received by Manufacturer: 12/24/2025
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 12/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male