MAUDE Adverse Event Report: SYNTHES GMBH LOCKING SCREW FOR IM NAIL Ø 5.0MM / L 36MM / XL25/ STER; NAIL, FIXATION, BONE

Catalog Number	04.045.036TS
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2026
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 that on(b)(6) 2026, the patient underwent an unknown surgery.Before inserting the screw in question, the surgeon tried to attach it to the screwdriver, but it did not fit properly even he/she pressed the screw against the screwdriver.Furthermore, when the screwdriver was turned while the screw was attached, only the screwdriver spun freely.It was decided that the screw was not in a condition to be used, and since there was a high possibility of causing trouble while insertion, the surgeon used another screw (04.045.038ts), which is 2 mm longer than the screw in question.04.045.038ts could be attached to the screwdriver without any problem, and the procedure was completed successfully.The surgery was completed successfully within a 30-minute delay.Since it was noticed before insertion, there was no effect on the patient.No further information is 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: 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: 04.045.036ts.Lot number: 67751p8.It was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 26 jun 2025.Manufacturing site: jabil grenchen.Expiry date: 01 jun 2030.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: LOCKING SCREW FOR IM NAIL Ø 5.0MM / L 36MM / XL25/ STER
• Common Device Name: NAIL, 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 ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 24482007
• Report Number: 8030965-2026-02061
• Device Sequence Number: 18711530
• Product Code: JDS
• UDI-Device Identifier: 10886982302656
• UDI-Public: (01)10886982302656(17)300601(10)67751P8
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K201346
• 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

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: 04.045.036TS
• Device Lot Number: 67751P8
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2026
• Supplement Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/19/2025
• 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
• Patient Sex: Unknown