MAUDE Adverse Event Report: SYNTHES (U.S.A.) LP; WIRE, SURGICAL

Model Number	292.65
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
K-wire threaded tip broke and retained in patient's right femur.Broken piece seen on fluro imaging.Attending surgeon did not attempt to recover retained piece.

• Brand Name: NA
• Common Device Name: WIRE, SURGICAL
• Manufacturer (Section D): SYNTHES (U.S.A.) LP; 1210 ward ave; west chester PA 19380
• MDR Report Key: 11444724
• Report Number: 11444724
• Device Sequence Number: 17048643
• Product Code: LRN
• UDI-Device Identifier: 10886982180742
• UDI-Public: (01)10886982180742
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/10/2021
• Report Date (Section F): 02/10/2021

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: 292.65
• Device Catalogue Number: 29265
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/09/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/09/2021
• 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: 02/10/2021