MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO L. MED AGGR BLADE (31MMX9MM)S; BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL

Model Number	2296003225
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device not returned.
Event or Problem Description
It was reported via medwatch report (b)(4) that during a total knee prosthesis procedure, a piece of the mini oscillating saw blade broke off during the explant portion of the procedure.It was also reported that an intraoperative x-ray was performed prior to final closure.The delay included the x-ray and the attempt to locate the missing piece.It was further reported that there were no adverse consequences as a results of this event and the procedure was completed successfully.
Additional Manufacturer Narrative
H6: the quality investigation is complete.
Event or Problem Description
It was reported via medwatch report 3100120000-2020-8006 that during a total knee prosthesis procedure, a piece of the mini oscillating saw blade broke off during the explant portion of the procedure.It was also reported that an intraoperative x-ray was performed prior to final closure.The delay included the x-ray and the attempt to locate the missing piece.It was further reported that there were no adverse consequences as a results of this event and the procedure was completed successfully.

• Brand Name: L. MED AGGR BLADE (31MMX9MM)S
• 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: 10295054
• Report Number: 0001811755-2020-01745
• Device Sequence Number: 19441144
• Product Code: GFA
• UDI-Device Identifier: 04546540046550
• UDI-Public: 04546540046550
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2020

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: 2296003225
• Device Catalogue Number: 2296003225
• Device Lot Number: UNKOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/24/2020
• Supplement Date Received by Manufacturer: 06/24/2020
• Initial Report FDA Received Date: 07/20/2020
• Supplement Report FDA Received Date: 08/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1