MAUDE Adverse Event Report: CONMED 12.5 X 76 X 0.9MM RECIPROCATOR BLADE, RIBBED, COATED; FLAT BLADE

Catalog Number	00505217900
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device was returned to conmed for evaluation.Visual inspection verified the device broke at the shaft.This breakage was most like caused by excessive force applied to the device during use by the user.A review of the manufacturing documents has verified the devices were produced per current and approved procedures and material specifications.Non-conformances regarding the product's identity, quality, safety, effectiveness or performance were not identified during manufacture that would contribute to this issue.A two-year review of complaint data revealed this is the only complaint for this product and failure combination.(b)(4).A risk analysis was completed and this incident was deemed to be acceptable.The instructions for use advise the user of the following.-inspect for bent, dull or damaged blades/burs before each use.-do not attempt to straighten or sharpen.-do not use if damaged.-avoid contact with blades/burs with cutting blocks, retractors or other instruments.-do not use burs for plunge cutting.Injury or damage may occur.-do not use saw blades to pry, remove bone grafts, or as a leverage point.Patient or user injury could occur.This incident type will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The user facility reported to conmed (b)(4) that during a total knee arthroscopy, the 00505217900 saw blade broke.The broken piece was retrieved from the surgical site and the procedure was completed using an alternative device.No patient injury or surgical delay was reported.This report is raised on the basis of a reported device malfunction with potential for patient injury with recurrence.

• Brand Name: 12.5 X 76 X 0.9MM RECIPROCATOR BLADE, RIBBED, COATED
• Common Device Name: FLAT BLADE
• Manufacturer (Section D): CONMED; 11311 concept blvd; largo FL 33773
• MDR Report Key: 6959318
• Report Number: 1017294-2017-00112
• Device Sequence Number: 1142104
• Product Code: GFA
• UDI-Device Identifier: 20845854000646
• UDI-Public: (01)20845854000646(17)220515(30)5(10)835519
• 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): 10/18/2017

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: 05/15/2022
• Device Catalogue Number: 00505217900
• Device Lot Number: 835519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2017
• Initial Report FDA Received Date: 10/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1