MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO RECIPROCATING BLADE, DOUBLE SIDED, OFFSET (70.0 X 0.8 X 12.5MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL

Catalog Number	0277096276
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting product return.
Event or Problem Description
It was reported that during a total knee surgery, the blade broke.It was also reported that there was a minor delay to open new blade and the procedure was completed successfully.It was further reported that the complainant was not aware of medical intervention or adverse consequences as a result of this event.
Additional Manufacturer Narrative
Investigation results indicate that the blade was bent during use as well as potentially coming in contact with other surgical equipment from the wear noted on the teeth of the blade.The ifu's of the handpieces for use with this blade was reviewed and contains warnings against bending of blades as follows: "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 total knee surgery, the blade broke.It was also reported that there was a minor delay to open new blade and the procedure was completed successfully.It was further reported that the complainant was not aware of medical intervention or adverse consequences as a result of this event.

• Brand Name: RECIPROCATING BLADE, DOUBLE SIDED, OFFSET (70.0 X 0.8 X 12.5MM)
• 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: 8232120
• Report Number: 0001811755-2019-00060
• Device Sequence Number: 1621215
• Product Code: GFA
• UDI-Device Identifier: 04546540880673
• UDI-Public: 04546540880673
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2019

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: 10/01/2023
• Device Catalogue Number: 0277096276
• Device Lot Number: 18276017
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/14/2018
• Supplement Date Received by Manufacturer: 02/18/2019
• Initial Report FDA Received Date: 01/09/2019
• Supplement Report FDA Received Date: 02/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1