MAUDE Adverse Event Report: CONMED CORPORATION BIOSCREW HYPERFLEX GUIDEWIRES, 356MM (14 IN.), QTY 5; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	C8026
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The customer reported that c8026 device was being used on during an acl procedure on (b)(6) 2019 when the guidewire broke in the graft.The device fragments were removed.There was no report of injury to the patient or the user.There was no report of medical intervention or hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Additional information: g3 - medwatch mw5091850 received after notification from user facility.This information has been added as additional information.Manufacturer narrative: visual examination of returned used device confirmed the reported problem and found the nitinol wire misused, bent and broken off at the etch line.The broken piece is approximately 1.500 -inches and was not returned for evaluation.Critical dimensions were measured and met design specifications.This is a technique dependent device and the most likely cause of this issue is user related.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 was 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 4 complaints, regarding 4 devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.(b)(4).Per the instructions for use, the user is advised the following: warnings: the use of a washer/sanitizer or disinfection solution may affect the life expectancy of the device.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: BIOSCREW HYPERFLEX GUIDEWIRES, 356MM (14 IN.), QTY 5
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd.; largo, fl FL 33773
• MDR Report Key: 9488411
• Report Number: 1017294-2019-00160
• Device Sequence Number: 234341
• Product Code: LXH
• UDI-Device Identifier: 10845854016671
• UDI-Public: (01)10845854016671(11)191030(10)1059046
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K941711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2020

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 Catalogue Number: C8026
• Device Lot Number: 1059046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Initial Date Received by Manufacturer: 12/13/2019
• Supplement Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 02/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1