MAUDE Adverse Event Report: CONMED CORPORATION RASP LIBERATOR KNIFE II, 4.75X149MM; ARTHROSCOPIC RASP

Model Number	25.50016
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint is confirmed.Evaluation found the tip of the rasp liberator knife broken off.The broken piece was returned for evaluation and is approximately 0.340 inches long.Also found damage on the handle end.Inspection was performed and could not find any discrepancies with critical dimensions.This is a technique-dependent device and the most likely cause of this failure is user-related.Suspect that excessive force was used that caused the tip of the rasp liberator knife to break off and suspect that the device was dropped during use due to damage of the handle.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 1 complaint regarding 1 device for this device family and failure mode.During the same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed, the rate of failure would be (b)(4).Per the instructions for use, the user is advised the following; not to use excessive force on instruments to avoid damage during use.Avoid unintended contact with other surgical instruments during use to prevent damage or breakage.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The customer reported the 25.50016, liberator rasp, broke during a bankart procedure.The tip was retrieved from the patient using arthroscopic graspers.The surgery was completed as planned.There was a delay in surgery, though the delay time was not reported.The procedure was completed using another rasp.Pictures were provided of the broken instrument.This report is being raised based on device malfunction with potential for injury upon reoccurrence.

• Brand Name: RASP LIBERATOR KNIFE II, 4.75X149MM
• Common Device Name: ARTHROSCOPIC RASP
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept boulevard; largo FL 33773
• MDR Report Key: 8453541
• Report Number: 1017294-2019-00033
• Device Sequence Number: 18921047
• Product Code: HTR
• UDI-Device Identifier: 10845854024478
• UDI-Public: (01)10845854024478(11)181220(10)986015
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/26/2019

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 Model Number: 25.50016
• Device Catalogue Number: 25.50016
• Device Lot Number: 986015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2019
• Initial Report FDA Received Date: 03/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1