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	Bone Fracture(s) (1870)
Date of Event	02/09/2021
Type of Reportable Event	Serious Injury
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 a photograph was 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, return of the device 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.Product surveillance will continue to monitor for trends.
Event or Problem Description
When the reamer was introduced into the femur on hand power it snapped off with a portion left into the femur.Which resulted in the surgeon cutting a window distally to retrieve the broken piece.The femur also fractured which required a restoration hip stem.It added 2 hours to the surgery.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a partnership reamer was reported.The event was confirmed via evaluation of the returned device.Method & results: -device evaluation and results: visual inspection: visual inspection was performed as part of the material analysis: "shows the tapered starter/sizer with fracture location labelled.On visual examination, the reported fracture occurred approximately 182 mm from the tip of the shank." material analysis: a material analysis was performed and concluded the following: "review of the 8-10mm tapered starter/sizer, catalogue # 6266-5-308 confirmed fracture of the component.Characterisation using stereo microscopy and scanning electron microscopy confirmed the component fractured in overload at the intersection between the shank and the fluted region.No manufacturing or material related defects were observed on the examined areas of the component." -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: it was reported that the reamer broke during surgery and that an intraoperative fracture also occurred as a result.A material analysis was performed on the returned device which concluded the following: "review of the 8-10mm tapered starter/sizer, catalogue # 6266-5-308 confirmed fracture of the component.Characterisation using stereo microscopy and scanning electron microscopy confirmed the component fractured in overload at the intersection between the shank and the fluted region.No manufacturing or material related defects were observed on the examined areas of the component." no further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
When the reamer was introduced into the femur on hand power it snapped off with a portion left into the femur.Which resulted in the surgeon cutting a window distally to retrieve the broken piece.The femur also fractured which required a restoration hip stem.It added 2 hours to the surgery.

• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 11423116
• Report Number: 0002249697-2021-00382
• Device Sequence Number: 3243076
• Product Code: LXH
• UDI-Device Identifier: 07613327219685
• UDI-Public: 07613327219685
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2023

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: 6266-5-308
• Device Catalogue Number: 6266-5-308
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 05/23/2023
• Initial Report FDA Received Date: 03/05/2021
• Supplement Report FDA Received Date: 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 70 KG