MAUDE Adverse Event Report: SYNTHES (U.S.A.) LP; SCREW, FIXATION, BONE

Model Number	214.772
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Placing a synthes 4.5 cann screw fully threaded 72 mm ref 214.772 into patients left foot.When taken, x-ray after placement of screw doctor noted the head of the screw appeared to have broken.

• Brand Name: NA
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES (U.S.A.) LP; 1210 ward ave; west chester PA 19380
• MDR Report Key: 11965044
• Report Number: 11965044
• Device Sequence Number: 3193997
• Product Code: HWC
• UDI-Device Identifier: 10886982154538
• UDI-Public: (01)10886982154538
• 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): 05/25/2021
• Report Date (Section F): 05/25/2021

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: No Information
• Device Model Number: 214.772
• Device Catalogue Number: 214772
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/09/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 05/25/2021