MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 2108 SERIES SAGITTAL BLADE (12.5 X 0.64 X 73.8MM); BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number	2108150000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The quality investigation is complete.
Event or Problem Description
Per medwatch report, it was reported that during a procedure, the blade broke at the mount.All the blade pieces were removed from the wound.It was also reported that there were no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.

• Brand Name: 2108 SERIES SAGITTAL BLADE (12.5 X 0.64 X 73.8MM)
• 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
• Manufacturer (Section G): STRYKER INSTRUMENTS-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA
• Manufacturer Contact: una barry ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 15536977
• Report Number: 3015967359-2022-01848
• Device Sequence Number: 6972174
• Product Code: GFA
• UDI-Device Identifier: 04546540042156
• UDI-Public: 04546540042156
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/04/2022

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: 11/01/2025
• Device Model Number: 2108150000
• Device Catalogue Number: 2108150000
• Device Lot Number: 20308027
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/07/2022
• Initial Report FDA Received Date: 10/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/03/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK_INS, SN UNKNOWN
• Patient Sex: Unknown