MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO DUAL CUT SAGITTAL BLADE (18X1.27X100MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL

Model Number	4118127100
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device discarded.
Event or Problem Description
It was reported that a blade broke during a total knee arthroplasty procedure.It was further reported that the procedure was completed successfully using a spare blade.It was also reported that there were no delays and no adverse consequences as a result of this event.
Additional Manufacturer Narrative
The reported event, for blade breakage, was not confirmed as the blade was not returned for evaluation.Without the blade, the root cause cannot be determined.Device not available for return.
Event or Problem Description
It was reported that a blade broke during a total knee arthroplasty(tka) procedure.It was further reported that the procedure was completed successfully using a spare blade.It was also reported that there were no delays and no adverse consequences as a result of this event.

• Brand Name: DUAL CUT SAGITTAL BLADE (18X1.27X100MM)
• 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: 9676534
• Report Number: 0001811755-2020-00413
• Device Sequence Number: 2757139
• Product Code: GFA
• UDI-Device Identifier: 04546540216892
• UDI-Public: 04546540216892
• Combination Product (Y/N): N
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2020

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: 4118127100
• Device Catalogue Number: 4118127100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/10/2020
• Supplement Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 02/06/2020
• Supplement Report FDA Received Date: 03/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1