MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 8-10MM STARTER/SIZER AWL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	6266-5-308
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
Primary procedure, right hip.It was reported that while manually inserting the starter reamer into the patient's femur, the instrument broke in half.Both pieces were removed and put together at the back table to ensure nothing remained in the patient.Surgery was completed successfully with a delay of approximately 10-12 minutes.Rep reported that a picture of the device can be provided and confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a partnership reamer was reported.The event was confirmed via visual inspection of the provided photograph of the device.Method & results: -product evaluation and results: the reported device was not returned however photographs were provided for review.Visual inspection of the provided photograph of the device indicated that it has broken into two pieces.The device is covered in blood.Nothing further can be determined from the photograph.-clinician review: no medical records were received for review with a clinical consultant.-product history review: could not be performed as the device lot details were not provided.-complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the reamer broke during surgery.The reported device was not returned however photographs were provided for review.Visual inspection of the provided photograph of the device indicated that it has broken into two pieces.The device is covered in blood.Nothing further can be determined from the photograph.The exact cause of the event could not be determined because insufficient information was provided.Further information such as device lot code information and return of the device are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Primary procedure, right hip.It was reported that while manually inserting the starter reamer into the patient's femur, the instrument broke in half.Both pieces were removed and put together at the back table to ensure nothing remained in the patient.Surgery was completed successfully with a delay of approximately 10-12 minutes.Rep reported that a picture of the device can be provided and confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: 8-10MM STARTER/SIZER AWL
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13729006
• Report Number: 0002249697-2022-00371
• Device Sequence Number: 14630203
• Product Code: LXH
• UDI-Device Identifier: 07613327219685
• UDI-Public: 07613327219685
• 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: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2022

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: 6266-5-308
• Device Catalogue Number: 6266-5-308
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2022
• Supplement Date Received by Manufacturer: 07/28/2022
• Initial Report FDA Received Date: 03/11/2022
• Supplement Report FDA Received Date: 08/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR
• Patient Sex: Male