MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 2108 SERIES SAGITTAL BLADE, NO OFFSET (18.6 X 1.24 X 105MM); BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number	2108185000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The quality investigation is complete.
Event or Problem Description
It was reported that during a tka procedure, the blade broke at the mount.It was also reported that there were no adverse consequences, no medical intervention and no delays as a result of this event.It was further reported that the procedure was completed successfully.

• Brand Name: 2108 SERIES SAGITTAL BLADE, NO OFFSET (18.6 X 1.24 X 105MM)
• 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: 15889638
• Report Number: 3015967359-2022-02368
• Device Sequence Number: 20108685
• Product Code: GFA
• UDI-Device Identifier: 04546540042279
• UDI-Public: 04546540042279
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 11/30/2022

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 Model Number: 2108185000
• Device Catalogue Number: 2108185000
• Device Lot Number: 22066017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2022
• Initial Report FDA Received Date: 11/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2022
• 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
• Patient Sex: Unknown