MAUDE Adverse Event Report: SYNTHES GMBH; BIT, DRILL

Model Number	03.133.104
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Drillbit broke during patient's procedure.

• Brand Name: NA
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): SYNTHES GMBH; 1302 wrights lane e; west chester PA 19380
• MDR Report Key: 19201770
• Report Number: 19201770
• Device Sequence Number: 8107256
• Product Code: HTW
• UDI-Device Identifier: 10886982269638
• UDI-Public: (01)10886982269638
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/29/2024
• Report Date (Section F): 01/29/2024

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
• Operator of Device: Health Professional
• Device Model Number: 03.133.104
• Device Catalogue Number: 03133104
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/29/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/29/2024
• 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: 83 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Date Report Sent to FDA: 01/29/2024