MAUDE Adverse Event Report: SYNTHES SYNTHES; BIT, DRILL

Model Number	323.062
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/30/2020
Type of Reportable Event	Malfunction
Event or Problem Description
While using 2.0 drill bit, bit broke in drill guide.

• Brand Name: SYNTHES
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): SYNTHES; 1303 goshen pkwy; west chester PA 19380
• MDR Report Key: 10104753
• Report Number: 10104753
• Device Sequence Number: 2240221
• Product Code: HTW
• UDI-Device Identifier: 00810041060372
• UDI-Public: (01)00810041060372
• 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): 04/30/2020
• Report Date (Section F): 04/30/2020

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: 323.062
• Device Lot Number: 41P6577
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/01/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 79
• Date Report Sent to FDA: 04/30/2020