MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP MICRO SAGITTAL BLADE OFFSET (13.0 X 0.51 X 50.0MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL

Model Number	2296003108S5
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.
Additional Manufacturer Narrative
H6: the quality investigation is complete.
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.

• Brand Name: MICRO SAGITTAL BLADE OFFSET (13.0 X 0.51 X 50.0MM)
• 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: 11757410
• Report Number: 0001811755-2021-00763
• Device Sequence Number: 3192783
• Product Code: GFA
• UDI-Device Identifier: 07613154631827
• UDI-Public: 07613154631827
• 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: 04/01/2025
• Device Model Number: 2296003108S5
• Device Catalogue Number: 2296003108S5
• Device Lot Number: 20107017
• 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