MAUDE Adverse Event Report: CONMED CORPORATION 4MM SUTURE PUNCH, STRAIGHT; ACCESSORIES, ARTHROSCOPIC

Catalog Number 18.1007

Device Problem Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/26/2018

Event Type  Injury  

Manufacturer Narrative

The reported device is expected to be returned for evaluation.A supplemental and final report will be filed upon the completion of the product evaluation and the complaint investigation.

Event Description

This distributor reported that the 18.1007, 4 mm suture punch, straight, broke while in use during a arthroscopic bankart repair on (b)(6) 2018.A second surgery was performed to remove the component from the patient.The component was successfully removed.Additional information was received stating there was no injury to patient; however, the current patient status was not available.This report is being raised as a injury due to secondary surgery required.

Manufacturer Narrative

Evaluation of the device by manufacturing engineering found the solder filling taped to the device.Further evaluation indicates the issue appears to be use/wear failure.This solder filling on this device is replaced every 5 years as it deteriorates over time.The cause of the failure is likely due to either a 3rd party repair or the device was losing small pieces of solder filling until it lost the entire piece.A service history review found no evidence of repairs for this device.The device was 17 years and 9 months of age at the time of the complaint.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 were found to have met all specifications prior to shipment.Per the instructions for use, the user is advised the following: precautions: inspect the instrument prior to use to ensure it is in good physical condition and functions properly.There should be no loose, broken or misaligned parts.Exercise care in the use of the device to minimize side or bending loads.Inspect instrument after use to ensure it has not been damaged.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: 4MM SUTURE PUNCH, STRAIGHT
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED CORPORATION; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: john berga ; 11311 concept blvd.; largo, FL 33773 ; 7273995358
• MDR Report Key: 7486277
• MDR Text Key: 107323610
• Report Number: 1017294-2018-00058
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 18.1007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2000
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other