MAUDE Adverse Event Report: CONMED LARGO EXOSHAPE SOFT TISSUE FASTENER FEMORAL, 9 MM X 21 MM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	1600-00-009
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the device, 1600-00-009, exoshape soft tissue fastener femoral, 9 mm x 21 mm, was being used during an unknown surgery on (b)(6) 2022 when it was reported, ¿we had another of these break today, tip broke off during implantation.¿ there was no report of injury, medical intervention, or hospitalization for the patient.Further assessment questioning found that tip broke off during implantation and fell into the surgical site, but was retrieved.Another implant was used to complete the surgery and the delay in time was "just to open another implant".This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Reported event of implant broke during implantation was confirmed.Visual examination of the returned used device, item 1600-00-009 confirmed the reported problem, and found implant broken off and still attached to the driver shaft.Improper delivery, implant did not deploy correctly and broke off.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 1 report, regarding 1 device, for this device family and failure mode.During this same time frame (b)(4) 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 (b)(4).Per the instructions for use, the user is advised the following: always handle the exoshape femoral soft tissue fastener carefully.The surface of the implant must always be protected from damage during handling.Avoid contacting the implant with other tools or materials that could notch, scratch, or otherwise damage the implant surface.Damage to the implant¿s surface finish may result in loss of proper mechanical function of the device.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.

• Brand Name: EXOSHAPE SOFT TISSUE FASTENER FEMORAL, 9 MM X 21 MM
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 13964794
• Report Number: 1017294-2022-00041
• Device Sequence Number: 19874681
• Product Code: MBI
• UDI-Device Identifier: 20845854082147
• UDI-Public: (01)20845854082147(17)230322(10)1191090
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K132783
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/31/2022

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 Expiration Date: 03/22/2023
• Device Catalogue Number: 1600-00-009
• Device Lot Number: 1191090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2022
• Initial Report FDA Received Date: 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic