MAUDE Adverse Event Report: STRYKER INSTRUMENTS-IRELAND RECIPROCATING BLADE HEAVY DUTY, OFFSET (77.5 X 1.23 X 11.0MM); BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number	0277096326
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/31/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The quality investigation is complete.
Event or Problem Description
It was reported that during a right elbow amputation procedure, the blade broke at the mount.It was also reported that there was an unknown delay as a result of this event, resulting in an increased time under anesthesia for the patient.It was further reported that the procedure was completed successfully.

• Brand Name: RECIPROCATING BLADE HEAVY DUTY, OFFSET (77.5 X 1.23 X 11.0MM)
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA
• Manufacturer (Section G): STRYKER INSTRUMENTS-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA
• Manufacturer Contact: una barry ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 14876714
• Report Number: 3015967359-2022-01230
• Device Sequence Number: 5098613
• Product Code: GFA
• UDI-Device Identifier: 04546540605627
• UDI-Public: 04546540605627
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/30/2022

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 Expiration Date: 05/01/2026
• Device Model Number: 0277096326
• Device Catalogue Number: 0277096326
• Device Lot Number: 21042027
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2021
• 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
• Patient Sex: Unknown