MAUDE Adverse Event Report: STRYKER TRAUMA SA; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-0050S
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
K-wire broke while in patient in operative site.

• Brand Name: NA
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA SA; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 12576054
• Report Number: 12576054
• Device Sequence Number: 19602627
• Product Code: LXH
• UDI-Device Identifier: 04546540195852
• UDI-Public: (01)04546540195852
• 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): 09/23/2021
• Report Date (Section F): 09/23/2021

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: Health Professional
• Device Model Number: 1806-0050S
• Device Catalogue Number: 1806-0050S
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/05/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 118
• Date Report Sent to FDA: 09/23/2021