MAUDE Adverse Event Report: CONMED CORPORATION 4.5MM-15MM LIBERATOR KNIFE; KNIFE, ORTHOPEDIC

Model Number	25.50014
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Examination confirmed the reported problem and found the tip broken off.The broken tip was returned for evaluation and is approximately 0.335 inches.Broken tip was damaged at the cutting edges.Examination could not find any issues with critical dimensions.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 2 complaints regarding 2 devices 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; inspect instruments after use to ensure it has not been damaged.Do not use excessive force on instruments to avoid damage or breakage 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 that the 25.50014, 4.5mm liberator knife broke during a slap repair on (b)(6) 2018.It's reported the " tip part was broken after the surgeon was isolating labrum from humeral head.The broken piece fell inside of a patient's body, but it was removed using grasper.Surgery was completed successfully without an alternate device." there was no reported patient injury and a 1-minute reported delay of surgery.This report is being raised based on device malfunction with potential for injury upon reoccurrence.

• Brand Name: 4.5MM-15MM LIBERATOR KNIFE
• Common Device Name: KNIFE, ORTHOPEDIC
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept boulevard; largo FL 33773
• MDR Report Key: 8318151
• Report Number: 1017294-2019-00008
• Device Sequence Number: 2254325
• Product Code: HTS
• UDI-Device Identifier: 10845854024461
• UDI-Public: (01)10845854024461(11)180213(10)45993
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 02/07/2019

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: 25.50014
• Device Catalogue Number: 25.50014
• Device Lot Number: 45993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2019
• Initial Report FDA Received Date: 02/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR