MAUDE Adverse Event Report: Synthes GmbH STARDRIVE SCREWDRIVER SHAFT QC/T15

Catalog Number	314.116
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2026
Type of Reportable Event	Malfunction

• Brand Name: STARDRIVE SCREWDRIVER SHAFT QC/T15
• Common Device Name: Screwdriver
• Manufacturer (Section D): Synthes GmbH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): Synthes Haegendorf GmbH; im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: elba bello ; 1302 wrights lane east; west chester, PA 19380 ; +1(908)386-3534
• MDR Report Key: 50038633
• Report Number: 8030965-2026-07731
• Device Sequence Number: 13222609
• Product Code: HXX
• UDI-Device Identifier: 07611819740877
• UDI-Public: (01)07611819740877(10)28P9778
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: Exempt
• 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: 314.116
• Device Lot Number: 28P9778
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/30/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/14/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2019
• 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