MAUDE Adverse Event Report: Synthes GmbH 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 18MM; Screw, fixation, bone

Catalog Number	04.211.018TS
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2026, the patient underwent orif for a clavicle shaft fracture using the screw in question.The vacp was used for fixation.During screw insertion, excessive torque was continuously applied to the screw, resulting in screw fracture.The proximal one-third of the screw fractured, while the remaining distal two-thirds remained implanted in the patient.The surgery was completed successfully with the retained fragment left in the patient.According to the surgeon, the risk of screw fracture increased because the screw size had been reduced to 2.7 mm compared to the previous product.The surgery was completed successfully without any surgical delay.
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.

• Brand Name: 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 18MM
• Common Device Name: Screw, fixation, bone
• Manufacturer (Section D): Synthes GmbH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): Synthes Selzach; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; +1(908)386-3534
• MDR Report Key: 50854670
• Report Number: 8030965-2026-09633
• Device Sequence Number: 9652009
• Product Code: HWC
• UDI-Device Identifier: 10886982119018
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103243
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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: 04.211.018TS
• Device Lot Number: 462L209
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/19/2026
• 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 Age: 24 YR
• Patient Sex: Male