MAUDE Adverse Event Report: Synthes GmbH STARDRIVE SCREWDRIVER SHAFT T8 105MM

Catalog Number	314.467
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2026
Type of Reportable Event	Malfunction

• Brand Name: STARDRIVE SCREWDRIVER SHAFT T8 105MM
• Common Device Name: Screwdriver
• Manufacturer (Section D): Synthes GmbH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): Monument; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; +1(908)386-3534
• MDR Report Key: 50114570
• Report Number: 8030965-2026-07892
• Device Sequence Number: 5305574
• Product Code: HXX
• UDI-Device Identifier: 10886982188922
• UDI-Public: (01)10886982188922
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152239
• 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,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: 314.467
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/13/2026
• Supplement Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 08/03/2026
• Supplement Report FDA Received Date: 08/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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