MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH BOX CHISEL; CHISEL, SURGICAL, MANUAL

Model Number	6541-4-709
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2020
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
Tka due to right knee osteoarthritis.This is the first surgery.The blade of the box chisel was chipped and the bone (inside the box) was slightly scratched.There seems to be no health hazard.Watch the future progress.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a triathlon chisel was reported.The event was confirmed.Method & results: device evaluation and results: the reported device was not returned however photographs were provided for review.The photographs show the broken triathlon chisel.From the photographs provided there is evidence of crack/fracture for 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 reported device was not returned however photographs were provided for review.The photographs show broken triathlon chisel.From the photographs provided there is evidence of crack/fracture for the device.No further investigation for this event is possible at this time as no devices and/ or insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.H3 other text : device not returned.
Event or Problem Description
Tka due to right knee osteoarthritis.This is the first surgery.The blade of the box chisel was chipped and the bone (inside the box) was slightly scratched.There seems to be no health hazard.Watch the future progress.

• Brand Name: BOX CHISEL
• Common Device Name: CHISEL, SURGICAL, MANUAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10841561
• Report Number: 0002249697-2020-02457
• Device Sequence Number: 4135397
• Product Code: FZO
• UDI-Device Identifier: 07613327179347
• UDI-Public: 07613327179347
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2021

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: 6541-4-709
• Device Catalogue Number: 6541-4-709
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/22/2020
• Supplement Date Received by Manufacturer: 12/22/2020
• Initial Report FDA Received Date: 11/15/2020
• Supplement Report FDA Received Date: 01/14/2021
• 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