MAUDE Adverse Event Report: SYNTHES (U.S.A.); REAMER

Model Number	309.068
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/08/2019
Type of Reportable Event	Malfunction
Event or Problem Description
While trying to get a screw out of the device that was used to take out a previous screw, it broke into a few pieces.

• Brand Name: NA
• Common Device Name: REAMER
• Manufacturer (Section D): SYNTHES (U.S.A.); 1210 ward ave; west chester PA 19380
• MDR Report Key: 9207338
• Report Number: 9207338
• Device Sequence Number: 447250
• Product Code: HTO
• UDI-Device Identifier: 10886982185587
• UDI-Public: (01)10886982185587
• 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): 10/07/2019
• Report Date (Section F): 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 309.068
• Device Catalogue Number: 309068
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/18/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 119
• Date Report Sent to FDA: 10/08/2019