MAUDE Adverse Event Report: SYNTHES GMBH SCRDRIVER SHAFT 2.4 SHORT SELF-HOLDING F; SURGICAL SCREWDRIVER, REUSABLE

Catalog Number	314.453
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
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.Additional narrative: investigation summary the product was returned to depuy synthes for evaluation.Visual inspection of the returned device found that the tip of the screwdriver shaft 2.4 short self-holding f is stripped.The observed condition of the device is consistent with a component failure that was caused by exposure to unintended forces like overtightening the device while assemblance; or by using the device in a misaligned position.A functional test was unable to performed due to mating device was not received to asses the interaction, however due to observed condition during the visual inspection it can experienced the inability to hold mating devices as intended.The overall complaint was confirmed as the observed condition of the screwdriver shaft 2.4 short self-holding f would have contributed to the complained issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is required.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.Dimensional inspection: n/a device history part number: 314.453-15 lot number: 35909p3 manufacturing site: hägendorf release to warehouse date:07-oct-2024 a manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.Device history review part number: 314.453-15 lot number: 35909p3 manufacturing site: hägendorf release to warehouse date:07-oct-2024.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.
Event or Problem Description
It was reported that on (b)(6) 2025, the patient underwent unknown surgery.During surgery, the product in question could not hold a tcp 2.4 locking screw.The surgery was completed successfully with no surgical delay.The surgeon requested an investigation into quality control.No further information is available.

• Brand Name: SCRDRIVER SHAFT 2.4 SHORT SELF-HOLDING F
• Common Device Name: SURGICAL SCREWDRIVER, REUSABLE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): HÄGENDORF; im bifang 6; hägendorf 4614 ; SZ 4614
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 24129572
• Report Number: 8030965-2026-00692
• Device Sequence Number: 5457336
• Product Code: HXX
• UDI-Device Identifier: 10886982188854
• UDI-Public: (01)10886982188854(10)35909P3
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• 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

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: 314.453
• Device Lot Number: 35909P3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2024
• 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
• Patient Sex: Unknown