MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PERFORMANCE SERIES SAGITTAL BLADE (25.0X1.27X90MM); BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL.

Model Number	6125127090
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.
Event or Problem Description
It was reported that during a procedure the cutting end of the blade broke.It was also reported that an x-ray was performed to confirm there were no fragments remaining in the patient.It was also reported that there was a delay of approximately one hour.It was further reported there were no adverse consequences and the procedure was completed successfully.
Event or Problem Description
It was reported that during a procedure the cutting end of the blade broke.It was also reported that an x-ray was performed to confirm there were no fragments remaining in the patient.It was also reported that there was a delay of approximately one hour.It was further reported there were no adverse consequences and the procedure was completed successfully.
Additional Manufacturer Narrative
H6: the quality investigation is complete.

• Brand Name: PERFORMANCE SERIES SAGITTAL BLADE (25.0X1.27X90MM)
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL.
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 10844211
• Report Number: 0001811755-2020-03152
• Device Sequence Number: 19766238
• Product Code: GFA
• UDI-Device Identifier: 04546540501516
• UDI-Public: 04546540501516
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2021

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: 07/01/2025
• Device Model Number: 6125127090
• Device Catalogue Number: 6125127090
• Device Lot Number: 20191027
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/21/2020
• Supplement Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 11/16/2020
• Supplement Report FDA Received Date: 02/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1