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

Catalog Number	6125127090
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting device return to manufacturer.
Event or Problem Description
It was reported that during a surgical procedure, the blade broke.It was also reported that the broken piece was retrieved from the patient.It was further reported that there were was a 10 minute delay as a result of this event.It was also reported that there was no adverse consequences as a result of this event and the procedure was completed successfully.
Additional Manufacturer Narrative
Updated returned to manufacturer date investigation results indicate that the blade was under excessive force and came into contact with metal while cutting which contributed to the breaking of the blade.The ifu of handpieces associated with this device warn the user against this type of use: "do not apply excessive pressure, such as bending or prying, with the blade.Excessive pressure may bend or fracture the blade and result in tissue damage, loss of tactile control, and/or the ejection of blade fragments at a high velocity".The quality investigation is complete.
Event or Problem Description
It was reported that during a surgical procedure, the blade broke.It was also reported that the broken piece was retrieved from the patient.It was further reported that there were was a 10 minute delay as a result of this event.It was also reported that there was no adverse consequences as a result of this event and the procedure was completed successfully.

• 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: 8659624
• Report Number: 0001811755-2019-01870
• Device Sequence Number: 14014913
• Product Code: GFA
• UDI-Device Identifier: 04546540501516
• UDI-Public: 04546540501516
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2019

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: 02/01/2024
• Device Catalogue Number: 6125127090
• Device Lot Number: 19042027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2019
• Initial Date Received by Manufacturer: 05/10/2019
• Supplement Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 05/31/2019
• Supplement Report FDA Received Date: 07/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 7208000000 S/N, (B)(4); 7208000000 S/N, (B)(4)