MAUDE Adverse Event Report: CONMED LARGO BIOSCREW HYPERFLEX GUIDEWIRE NITINOL 14 IN STER; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number	C8006D
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.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 2 complaints, regarding 2 devices, for this device family and failure mode.During this same time frame 5,871 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 0.0003.Per the instructions for use, the user is advised to inspect guidewire prior to use and after removal to ensure it is in good physical condition and functions properly.Do not use if product is damaged.Do not kink (sharply bend) the guidewire prior to or during insertion.Breakage or insertion difficulty may occur if the interference screw is used with a kinked guidewire.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer, that c8006d, bioscrew hyperflex guidewire nitinol 14 in ster was being used during a hip arthroscopy procedure on approximately 27mar24 date when it was reported ¿the nitinol wire broke inside the patient during hip arthroscopy.¿.It was also reported that ¿recovering the broken piece of nitinol wire with difficulty.A new nitinol wire was given to continue the hip arthroscopy.¿.The procedure was completed with the use of an alternate device.There was no report of injury, medical intervention, or extended hospitalization to the patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: BIOSCREW HYPERFLEX GUIDEWIRE NITINOL 14 IN STER
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 19158168
• Report Number: 1017294-2024-00043
• Device Sequence Number: 7443958
• Product Code: MDM
• UDI-Device Identifier: 10845854041697
• UDI-Public: (01)10845854041697(17)270718(10)1258150
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/22/2024

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: C8006D
• Device Lot Number: 1258150
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2024
• Initial Report FDA Received Date: 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic