MAUDE Adverse Event Report: Synthes GmbH 2.0MM DRILL BIT W/DEPTH MARK QC/110MM; Bit, Surgical

Catalog Number	310.534
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/12/2026
Type of Reportable Event	Malfunction

• Brand Name: 2.0MM DRILL BIT W/DEPTH MARK QC/110MM
• Common Device Name: Bit, Surgical
• Manufacturer (Section D): Synthes GmbH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): Werk Bettlach (CH); muracherstrasse 3; bettlach CO 80132 ; SZ 80132
• Manufacturer Contact: elba bello ; 1302 wrights lane east; west chester, PA 19380 ; +1(908)386-3534
• MDR Report Key: 50672434
• Report Number: 8030965-2026-08940
• Device Sequence Number: 9539778
• Product Code: GFG
• UDI-Device Identifier: 07611819158962
• UDI-Public: (01)07611819158962(10)68P1228
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,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: 310.534
• Device Lot Number: 68P1228
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/12/2026
• Supplement Date Received by Manufacturer: 09/23/2026
• Initial Report FDA Received Date: 09/08/2026
• Supplement Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/14/2020
• 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