MAUDE Adverse Event Report: Synthes GmbH RETENTION PIN FOR SCREWDRIVER W/ Q C -HEX 12MM/SHORT/XL25

Catalog Number	03.045.008
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2026
Type of Reportable Event	Malfunction

• Brand Name: RETENTION PIN FOR SCREWDRIVER W/ Q C -HEX 12MM/SHORT/XL25
• 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: 50356170
• Report Number: 8030965-2026-08333
• Device Sequence Number: 20343465
• Product Code: HXX
• UDI-Device Identifier: 10886982292551
• UDI-Public: (01)10886982292551(10)84P5957
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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: 03.045.008
• Device Lot Number: 84P5957
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/19/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/24/2026; 08/25/2026
• Initial Report FDA Received Date: 08/20/2026
• Supplement Report FDA Received Date: 08/25/2026; 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2021
• 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