MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP RECIPROCATING BLADE, DOUBLE SIDED, OFFSET (70.0 X 1.27 X 12.5MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL

Model Number	0277096281
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting confirmation if device is available.
Event or Problem Description
It was reported that during a total hip arthroplasty procedure, the blade broke.It was also reported there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.
Additional Manufacturer Narrative
H6: investigation results indicate that the blade broke due to issues with the associated with a component failure within the associated handpiece.The quality investigation is complete.
Event or Problem Description
It was reported that during a total hip arthroplasty procedure, the blade broke.It was also reported there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.

• Brand Name: RECIPROCATING BLADE, DOUBLE SIDED, OFFSET (70.0 X 1.27 X 12.5MM)
• 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: 12188002
• Report Number: 3015967359-2021-01429
• Device Sequence Number: 5244557
• Product Code: GFA
• UDI-Device Identifier: 04546540880789
• UDI-Public: 04546540880789
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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 Health Care Professional
• Type of Report: Initial,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 Expiration Date: 08/01/2025
• Device Model Number: 0277096281
• Device Catalogue Number: 0277096281
• Device Lot Number: 20238027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2021
• Initial Date Received by Manufacturer: 06/22/2021
• Supplement Date Received by Manufacturer: 10/06/2021
• Initial Report FDA Received Date: 07/19/2021
• Supplement Report FDA Received Date: 10/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN HD RECIP HANDPIECE SAW