MAUDE Adverse Event Report: STRYKER TRAUMA KIEL K-WIRE GAMMA Ø3,2X450 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	12106450S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	10/05/2019
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
During an orthopedic surgery, a guide/blocking pin piece broke off; could not be removed, and the broken piece was left in the patient.Surgeon indicated that there are more risk to attempt to remove.
Event or Problem Description
During an orthopedic surgery, a guide/blocking pin piece broke off; could not be removed, and the broken piece was left in the patient.Surgeon indicated that there are more risk to attempt to remove.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the product was not returned for evaluation and no other evidence was provided.A device inspection was not possible since the affected device was not returned and no other evidence was provided for investigation.More information as well as the affected product must be available in order to determine the exact root cause of the failure.However, based on the risk management file and past complaint history some of the possible causes are but not limited to: bending and/or torsion overload, wrong entry point in the bone, etc.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.If the device is returned or any further information is provided, the complaint report will be updated.

• Brand Name: K-WIRE GAMMA Ø3,2X450 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 9257689
• Report Number: 0009610622-2019-00901
• Device Sequence Number: 10891747
• Product Code: LXH
• UDI-Device Identifier: 04546540175366
• UDI-Public: 04546540175366
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2019

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 Expiration Date: 12/30/2024
• Device Catalogue Number: 12106450S
• Device Lot Number: K07E3B4
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/05/2019
• Supplement Date Received by Manufacturer: 12/04/2019
• Initial Report FDA Received Date: 10/30/2019
• Supplement Report FDA Received Date: 12/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 83