MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 11-13MM STARTER/SIZER AWL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	6266-5-311
Medical Device Problem Codes	Fracture (1260); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Primary procedure, right hip.It was reported that the awl snapped at the mid-shaft of the femoral canal.A hole had to be cut in the patient's femur distally to the tip in order to remove all pieces of the device.Surgeon is an experienced user of the system and there was nothing unusual in the way the device was being used.Surgery was completed successfully with a delay of approximately 1 hour.Rep can provide pictures of the device and confirmed no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving an other instrument reamer was reported.The event was confirmed through visual inspection of the provided photographs.Method & results: device evaluation and results: no product was returned for evaluation, however two photographs were provided for review.The photographs show a fractured starter/sizer awl.Blood is visible on the device.Clinician review: no medical records were received for review with a clinical consultant.Device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusion: the event of crack/fracture was confirmed through visual inspection of the provided photographs.The exact cause of the event cannot be confirmed as insufficient information was provided.Additional information including device lot information and primary operative reports are required to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
Primary procedure, right hip.It was reported that the awl snapped at the mid-shaft of the femoral canal.A hole had to be cut in the patient's femur distally to the tip in order to remove all pieces of the device.Surgeon is an experienced user of the system and there was nothing unusual in the way the device was being used.Surgery was completed successfully with a delay of approximately 1 hour.Rep can provide pictures of the device and confirmed no further information will be released by the hospital or surgeon.

• Brand Name: 11-13MM STARTER/SIZER AWL
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10355090
• Report Number: 0002249697-2020-01581
• Device Sequence Number: 19738880
• Product Code: LXH
• UDI-Device Identifier: 07613327219692
• UDI-Public: 07613327219692
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 6266-5-311
• Device Catalogue Number: 6266-5-311
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 09/09/2020
• Initial Report FDA Received Date: 08/03/2020
• Supplement Report FDA Received Date: 10/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 73 YR