MAUDE Adverse Event Report: CONMED LARGO CONCEPT GRAFIX TENDON STRIPPER, 7.0MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number TS8850

Device Problem Material Fragmentation (1261)

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

Event Date 10/20/2021

Event Type  malfunction  

Event Description

On behalf of the customer, the conmed (b)(4) representative reported issues with the ts8850 , concept grafix tendon stripper, lot 60590, recently experienced on (b)(6) 2021 by (b)(6) hospital.Information received indicates the top of the concept grafix tendon stripper was broken during a reconstruction of the cruciate ligament.It is indicated there was no impact or injury to the patient.All pieces of the device were removed from the patient.There was nothing unusual noted regarding the patient¿s bone or anatomy.The procedure was successfully completed.Although requested, no other clarification was provided.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence, as although the pieces were removed, they did fall into the patient.

Manufacturer Narrative

At time of filing, the reported device is not expected to be returned to conmed for evaluation.This reported event is entering the investigation process.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

Investigation of the customer's reported event of ¿tip of the device broken during surgery¿ is confirmed.The device will not be returned for evaluation however photographic evidence has been provided.The image exhibits the reported claim nevertheless a root cause cannot be established a two-year lot history review was conducted and found no other similar events reported for this lot number.The service history was reviewed, and no data was found.The manufacturing documents from the device history record (dhr) have been reviewed by the supplier and determined the lot was manufactured march 16, 2021; a lot quantity of 50 device was manufactured.(b)(4).As this is a reusable device, the potential number of uses is not considered in this occurrence rate.The instructions for use (ifu) provides the user with information regarding proper care and use of this device.Also, per the ifu, the user is advised to inspect instrument prior to use to ensure it is in good physical condition and functions properly.There should be no loose, broken or misaligned parts.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

On behalf of the customer, the conmed china representative reported issues with the ts8850 , concept grafix tendon stripper, lot 60590, recently experienced on (b)(6) 2021 by (b)(4) hospital.Information received indicates the top of the concept grafix tendon stripper was broken during a reconstruction of the cruciate ligament.It is indicated there was no impact or injury to the patient.All pieces of the device were removed from the patient.There was nothing unusual noted regarding the patient¿s bone or anatomy.The procedure was successfully completed.Although requested, no other clarification was provided.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence, as although the pieces were removed, they did fall into the patient.

• Brand Name: CONCEPT GRAFIX TENDON STRIPPER, 7.0MM
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: tracey weiselbenton ; conmed corporation; 11311 concept blvd; largo, FL 33773 ; 7273995557
• MDR Report Key: 12781537
• MDR Text Key: 282612983
• Report Number: 1017294-2021-00356
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/14/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: TS8850
• Device Lot Number: 60590
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2021
• Initial Date FDA Received: 11/09/2021
• Supplement Dates Manufacturer Received: 11/15/2021
• Supplement Dates FDA Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic