MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PRECISION THIN (9.0 X 0.38 X 31.0MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL

Catalog Number	2296003225
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Awaiting device evaluation.A follow up report will be filed once the quality investigation is complete.
Event or Problem Description
It was reported that two blades broke at the mount during a high tibial osteotomy.It was also reported that there was a delay of a few minutes to obtain a replacement blade.It was further reported that the procedure was completed successfully and there were no adverse consequences as a result of this event.This report is for the first blade that broke.
Event or Problem Description
It was reported that two blades broke at the mount during a high tibial osteotomy.It was also reported that there was a delay of a few minutes to obtain a replacement blade.It was further reported that the procedure was completed successfully and there were no adverse consequences as a result of this event.This report is for the first blade that broke.
Additional Manufacturer Narrative
Investigation results indicate that the blade mount on both sides were possibly exposed to a torsional loading while cutting.This type of loading could occur when applying a bending moment to the blade while in use.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 cause tissue damage and/or loss of tactile control".The quality investigation is complete.

• Brand Name: PRECISION THIN (9.0 X 0.38 X 31.0MM)
• 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: 8453341
• Report Number: 0001811755-2019-00945
• Device Sequence Number: 13788278
• Product Code: GFA
• UDI-Device Identifier: 04546540046550
• UDI-Public: 04546540046550
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2019

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: 12/01/2023
• Device Catalogue Number: 2296003225
• Device Lot Number: 18347027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2019
• Initial Date Received by Manufacturer: 02/27/2019
• Supplement Date Received by Manufacturer: 05/09/2019
• Initial Report FDA Received Date: 03/26/2019
• Supplement Report FDA Received Date: 05/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1