MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP PRECISION FALCON OSCILLATING TIP SAW CARTRIDGE (25 X 1.27 X 90MM); INSTRUMENT, SURGICAL, ORTHOPAEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	6725127090
Medical Device Problem Codes	Fracture (1260); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The quality investigation is complete.Awaiting device return.
Event or Problem Description
It was reported that during a right total knee arthroplasty procedure, the blade broke.It was further reported that the broken pieces were successfully removed from the patient and there was a five minute delay as a result of this event.It was further reported that there were no adverse consequences as a result of this event and the procedure was completed successfully.
Additional Manufacturer Narrative
H6: the quality investigation is complete.H3 other text: device not returned.
Event or Problem Description
It was reported that during a right total knee arthroplasty procedure, the blade broke.It was further reported that the broken pieces were successfully removed from the patient and there was a five minute delay as a result of this event.It was further reported that there were no adverse consequences as a result of this event and the procedure was completed successfully.
Additional Manufacturer Narrative
Corrected data: b5: upon evaluation of the returned device, it was confirmed that the blade tip was not broken and this is not a reportable event.Additional narrative: h6: the quality investigation is complete.
Event or Problem Description
It was reported that during a right total knee arthroplasty procedure, the blade broke.It was further reported that the broken pieces were successfully removed from the patient and there was a five minute delay as a result of this event.It was further reported that there were no adverse consequences as a result of this event and the procedure was completed successfully.It was subsequently determined based on the evaluation of the returned device that the blade did not break, the cartridge split open at the side welds.

• Brand Name: PRECISION FALCON OSCILLATING TIP SAW CARTRIDGE (25 X 1.27 X 90MM)
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPAEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• MDR Report Key: 12052173
• Report Number: 3015967359-2021-01223
• Device Sequence Number: 3647641
• Product Code: HWE
• UDI-Device Identifier: 07613327143751
• UDI-Public: 07613327143751
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• 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,Followup
• Report Date (Section B): 10/12/2021

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: 6725127090
• Device Catalogue Number: 6725127090
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2021
• Initial Date Received by Manufacturer: 06/01/2021
• Supplement Date Received by Manufacturer: 08/12/2021; 10/07/2021
• Initial Report FDA Received Date: 06/23/2021
• Supplement Report FDA Received Date: 08/12/2021; 10/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1