MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SAGITTAL BLADE; BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL

Model Number	2108151001
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The quality investigation is complete.
Event or Problem Description
It was reported that the blade broke at the mount during a surgical procedure.It was also reported there was a slight delay and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.

• Brand Name: SAGITTAL BLADE
• 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: 12532534
• Report Number: 3015967359-2021-02065
• Device Sequence Number: 1337182
• Product Code: GFA
• UDI-Device Identifier: 04546540939401
• UDI-Public: 04546540939401
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 09/27/2021

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: 05/01/2026
• Device Model Number: 2108151001
• Device Catalogue Number: 2108151001
• Device Lot Number: 21138017
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 09/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1