MAUDE Adverse Event Report: CONMED CORPORATION BIOSCREW HYPERFLEX GUIDEWIRE

Catalog Number	C8026
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual examination of the returned used device, item c8026, confirms the reported problem and found the nitinol wire misused, bent and broken off at the etched line.The broken piece was also returned for evaluation.This is a technique dependent device and the most likely cause of this issue is user related.The manufacturing documents from a device history record have been reviewed with special attention to the manufacturing and inspection of the product.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 2 complaints, regarding 2 devices, for this device family and failure mode.During the same time frame 26,676 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.00007 per the instructions for use the user is advised the following; instrument is designed for use by surgeons experienced in the appropriate specialized procedures.It is the responsibility of the surgeon to become familiar with the proper techniques for use.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The customer reported that the 5129491, bioscrew hyperflex guidewire, broke during surgery.This caused a 2 hour delay, there was no reported patient injury, however, the extended time under anesthesia does impact the patient.Further attempts we made to get additional information but none was provided.This report is being raised on the basis of device malfunction with potential for injury upon reoccurrence.
Event or Problem Description
Additional information received: the customer reported that the c8026, bioscrew hyperflex guidewire, broke during surgery.This caused a 2 hour delay, there was no reported patient injury, however, the extended time under anesthesia does impact the patient.Further information was received on (b)(6) 2018 due to a medwatch.This new information explained the 2 hour delay; part of the guidewire was broken off into the allograft.Flouroscopy was used to remove the broken piece, but by doing so, it also destroyed the allograft.The surgeon had to replace the allograft with a new one.The surgeon used x-ray to confirm all the pieces were retrieved.This report is being raised on the basis of device malfunction with potential for injury upon reoccurence.
Additional Manufacturer Narrative
Corrections: was previously 10/2/18 corrected to 9/26/18 udi (b)(4).This issue will continue to be monitored through the complaint system to assure patient safety.
Additional Manufacturer Narrative
Additional information was added to b5, due to new information provided to conmed via a medwatch report number mw5079894.This did not change any of the evaluation reults or patient outcome.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
Additional information received: the customer reported that the 5129491, bioscrew hyperflex guidewire, broke during surgery.This caused a 2 hour delay, there was no reported patient injury, however, the extended time under anesthesia does impact the patient.Further information was received on (b)(6), 2018 due to a medwatch.This new information explained the 2 hour delay; part of the guidewire was broken off into the allograft.Flouroscopy was used to remove the broken piece, but by doing so, it also destroyed the allograft.The surgeon had to replace the allograft with a new one.The surgeon used x-ray to confirm all the pieces were retrieved.This report is being raised on the basis on device malfunction with potential for injury upon reoccurence.

• Brand Name: BIOSCREW HYPERFLEX GUIDEWIRE
• Common Device Name: GUIDEWIRE
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept boulevard; largo FL 33773
• MDR Report Key: 7933649
• Report Number: 1017294-2018-00154
• Device Sequence Number: 16522426
• Product Code: LXH
• UDI-Device Identifier: 10845854016671
• UDI-Public: (01)10845854016671(11)80727(30)
• 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: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/12/2018

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 Catalogue Number: C8026
• Device Lot Number: 949037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2018
• Initial Date Received by Manufacturer: 09/07/2018
• Supplement Date Received by Manufacturer: 10/10/2018; 10/10/2018
• Initial Report FDA Received Date: 10/04/2018
• Supplement Report FDA Received Date: 11/12/2018; 11/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1