MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP PRECISION OFFSET (9.0 X 0.64 X 35.0MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL

Model Number	2296033520
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting return of device to manufacturer.
Event or Problem Description
It was reported that during a surgical procedure, it was noted that three blades broke where it fits into the handpiece.It was also reported there was a delay of 10 minutes as a result of this event.It was further reported that no adverse consequences occurred as a result of this event.It was further reported that the procedure was completed successfully.This record addresses one of the three blades which were reported to have broken.
Event or Problem Description
It was reported that during a surgical procedure, it was noted that three blades broke where it fits into the handpiece.It was also reported there was a delay of 10minutes as a result of this event.It was further reported that no adverse consequences occurred as a result of this event.It was further reported that the procedure was completed successfully.This record addresses one of the three blades which were reported to have broken.
Additional Manufacturer Narrative
H6: the quality investigation is complete.

• Brand Name: PRECISION OFFSET (9.0 X 0.64 X 35.0MM)
• 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: 11757407
• Report Number: 0001811755-2021-00761
• Device Sequence Number: 16942084
• Product Code: GFA
• UDI-Device Identifier: 04546540466693
• UDI-Public: 04546540466693
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2021

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: 05/01/2025
• Device Model Number: 2296033520
• Device Catalogue Number: 2296033520
• Device Lot Number: 20148017
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/06/2021
• Supplement Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 06/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1