MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP RECIPROCATING BLADE HEAVY DUTY (87.9 X 1.27 X 12.2MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL

Model Number	5301020061S1
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting device return.
Event or Problem Description
It was reported that three blades broke during a total hip arthroplasty procedure.It was further reported there was a 5 minute delay to obtain a new blade.It was also reported that there were no adverse consequences and the procedure was completed successfully.This report is for the first blade that broke.
Additional Manufacturer Narrative
H6: the quality investigation is complete.
Event or Problem Description
It was reported that three blades broke during a total hip arthroplasty procedure.It was further reported there was a 5 minute delay to obtain a new blade.It was also reported that there were no adverse consequences and the procedure was completed successfully.This report is for the first blade that broke.

• Brand Name: RECIPROCATING BLADE HEAVY DUTY (87.9 X 1.27 X 12.2MM)
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• MDR Report Key: 12167074
• Report Number: 3015967359-2021-01405
• Device Sequence Number: 3705395
• Product Code: GFA
• UDI-Device Identifier: 07613153095606
• UDI-Public: 07613153095606
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2021

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 Expiration Date: 08/01/2025
• Device Model Number: 5301020061S1
• Device Catalogue Number: 5301020061S1
• Device Lot Number: 20240017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2021
• Initial Date Received by Manufacturer: 06/21/2021
• Supplement Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 07/14/2021
• Supplement Report FDA Received Date: 08/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1