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

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/13/2022

Event Type  Injury  

Event Description

The sales representative reported on behalf of the customer that the 1600-00-009, exoshape soft tissue fastener femoral, 9 mm x 21 mm, was used during an unknown procedure originally on (b)(6) 2018.¿within the last 2 weeks patient fell and half of the implant came out and was floating around in the joint.A 2nd surgery was required to remove.¿ the secondary surgery occurred on (b)(6) 2022.The fragment was removed from the patient during outpatient surgery.There was no report of initial or prolonged hospitalization for the second surgery.The patient¿s current status is unknown.This report is being raised on the basis of injury due to secondary surgery being required to remove fragmentation.

Manufacturer Narrative

The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Manufacturer Narrative

The device is not being 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 one complaint, regarding one 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 that this device is contraindicated for patients with an active local or systemic infection.Conditions which tend to retard healing such as blood supply limitations or previous infections.Skeletally immature patients where the implanted device would cross open epiphyseal plates.Insufficient quality or quantity of bone, comminuted bone surfaces, or pathologic conditions such as cystic change or severe osteopenia that would impair the ability of the exoshape femoral soft tissue fastener to securely fixate to the bone.Inadequate neuromuscular status (e.G.Paralysis, inadequate muscle strength).This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The sales representative reported on behalf of the customer that the 1600-00-009, exoshape soft tissue fastener femoral, 9 mm x 21 mm, was used during an unknown procedure originally on (b)(6) 2018.¿within the last 2 weeks patient fell and half of the implant came out and was floating around in the joint.A 2nd surgery was required to remove.¿ the secondary surgery occurred on 13may22.The fragment was removed from the patient during outpatient surgery.There was no report of initial or prolonged hospitalization for the second surgery.The patient¿s current status is unknown.This report is being raised on the basis of injury due to secondary surgery being required to remove fragmentation.

• Brand Name: EXOSHAPE SOFT TISSUE FASTENER FEMORAL, 9 MM X 21 MM
• Type of Device: 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: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 14575141
• MDR Text Key: 293485330
• Report Number: 1017294-2022-00065
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• PMA/PMN Number: K132783
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 1600-00-009
• Device Lot Number: 02340
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/13/2022
• Initial Date FDA Received: 06/02/2022
• Supplement Dates Manufacturer Received: 06/15/2022
• Supplement Dates FDA Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2017
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 19 YR
• Patient Sex: Male
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic