MAUDE Adverse Event Report: STRYKER TRAUMA KIEL SCREWDRIVER BIT IMPLANT EXTRACTION SET T15; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-6119
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device is not available; disposed by hospital.
Event or Problem Description
As reported: "patient had an infection which led to the removal of all the plate and screws.We were doing a tibial plate removal of plate and screws at (b)(6).One of screws were very tight and first couple of attempts of taking screws was unsuccessful.When the surgeon went to torque the driver, the tip of the screw driver snapped off.The crack piece was not retrieved it was thrown away at the facility.Procedure was completed successfully, used another screwdriver and it worked.No impact to the patient.Roughly a 30 sec- 1 minute delay.

• Brand Name: SCREWDRIVER BIT IMPLANT EXTRACTION SET T15
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 11865466
• Report Number: 0009610622-2021-00522
• Device Sequence Number: 3193859
• Product Code: LXH
• UDI-Device Identifier: 07613154403851
• UDI-Public: 07613154403851
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/21/2021

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: 1806-6119
• Device Catalogue Number: 18066119
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 05/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 24 YR