MAUDE Adverse Event Report: SYNTHES GMBH; BIT, DRILL

Model Number	03.133.103
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During left lateral tibia open reduction and internal fixation (orif) with allograft, while the surgeon was using the drill bit, the tip of the drill broke off in the bone.Surgeon used c-arm to confirm, broken piece in bone.

• Brand Name: NA
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): SYNTHES GMBH
• MDR Report Key: 20557191
• Report Number: 20557191
• Device Sequence Number: 11538952
• Product Code: HTW
• UDI-Device Identifier: 10886982269621
• UDI-Public: (01)10886982269621
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/14/2024
• Report Date (Section F): 08/14/2024

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
• Device Model Number: 03.133.103
• Device Catalogue Number: 03133103
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 10/29/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/29/2024
• 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 Age: 27 YR
• Patient Sex: Female
• Patient Weight: 121 KG
• Date Report Sent to FDA: 08/14/2024