MAUDE Adverse Event Report: CONMED CORPORATION STRYKER OSCILLATING SAW BLADE REPLACEMENT 19MM X 1.27MM (0.050 INCH) X 90MM, QTY; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	STK190-127-90
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The alleged broken stk190-127-90 is not expected to be returned for evaluation and review due to being disposed of at the hospital per the reporting.This complaint of broken device is unable to be verified and a root cause cannot be determined.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution were found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 16 complaints, regarding 24 devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).Per the handpiece instructions for use, the user is advised the following: precautions: direct contact of the rotating cutting edge of shaver blades and burs with metallic surfaces and/or other hard surfaces such as arthroscopes, cannulas, or other instruments can cause damage to the device.If contact does occur, shaver blades can break, seize, or shed metal particles.Shaver blade or bur should be examined for damage and replaced if necessary.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the stk190-127-90, stryker oscillating saw blade replacement 19 mm x 1.27 mm (0.050 inch) x 90 mm, qty 5, device broke during a total knee arthroscopy procedure on (b)(6) 2018.At initial reporting, it was stated that a piece of the device was lost; however, after completion of the customer complaint form during the procedure the patient was x-rayed and the fragment was found and removed.To complete the procedure another device was used, and the procedure completed successfully with a 5-minute delay.There was no report of injury to the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: STRYKER OSCILLATING SAW BLADE REPLACEMENT 19MM X 1.27MM (0.050 INCH) X 90MM, QTY
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd.; largo FL 33773
• MDR Report Key: 7834323
• Report Number: 1017294-2018-00143
• Device Sequence Number: 1964009
• Product Code: GFA
• UDI-Device Identifier: 10845854020821
• UDI-Public: (01)10845854020821(17)230608(10)934584
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/30/2018

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: 06/08/2023
• Device Catalogue Number: STK190-127-90
• Device Lot Number: 934584
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 08/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 76