MAUDE Adverse Event Report: STRYKER TRAUMA KIEL CROWN DRILL IMPLANT EXTRACTION SET 3 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-6165
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2020
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.
Event or Problem Description
As reported in medwatch (b)(4): "during a surgical procedure (right patellar tendon repair, long leg splint support for protection of the right knee joint), the stryker drill bit broke leaving a piece of the drill bit in the patient's knee.The piece of broken drill bit was removed by the surgeon.".

• Brand Name: CROWN DRILL IMPLANT EXTRACTION SET 3 MM
• 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: 11305220
• Report Number: 0009610622-2021-00277
• Device Sequence Number: 4959424
• Product Code: LXH
• UDI-Device Identifier: 04546540510013
• UDI-Public: 04546540510013
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/09/2021

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: 1806-6165
• Device Catalogue Number: 18066165
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 02/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 36 YR