MAUDE Adverse Event Report: CLASSIC WIRE CUT CO, INC. 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 06/29/2022

Event Type  Injury  

Event Description

The distributor reported on behalf of the customer that the device, ts8850 concept grafix tendon stripper, 7.0mm was being used on (b)(6) 2022 during an anterior cruciate ligament reconstruction and ¿a new tendon stripper is broken at the tip during acl case.The tip fell inside the patient as per attached image 1 which made more incision to the patient and 5 hours delay¿.The procedure was completed without an alternate device.After further assessment it was found that the fragment was retrieved using a c-arm for position detection and kocher instruments.Two more incisions were made with lengths of 3 cm and 4 cm on the posterior medial femur to extract the fragment.Patient was not injured but is asking about why there are extra incisions needed.No extended hospitalization was needed.This report is being raised on the basis of injury due to extra incisions to extract the fragment.

Manufacturer Narrative

Patient weight is between 60kg-70kg.Manufacturer narrative: the reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.Device not yet received.

Event Description

The distributor reported on behalf of the customer that the device, ts8850 concept grafix tendon stripper, 7.0mm was being used on (b)(6) 2022 during an anterior cruciate ligament reconstruction and ¿a new tendon stripper is broken at the tip during acl case.The tip felt inside the patient as per attached image 1 which made more incision to the patient and 5 hours delay¿.The procedure was completed without an alternate device.After further assessment it was found that the fragment was retrieved using a c-arm for position detection and kocher instruments.Two more incisions were made with lengths of 3 cm and 4 cm on the posterior medial femur to extract the fragment.Patient was not injured but is asking about why there are extra incision needed.No extended hospitalization was needed.This report is being raised on the basis of injury due to extra incisions to extract the fragment.

Manufacturer Narrative

A4: patient weight between 60kg-70kg.Manufacturer narrative: the device is not being returned, but photographic evidence was provided that confirmed the reported problem.A two-year lot history review shows a total of two complaints for this lot number and failure mode.A review of the device history record from the supplier found no abnormalities that would contribute to this issue.A two-year review of complaint history revealed there has been a total of 5 reports, regarding 5 devices, for this device family and failure mode.During this same time frame 286 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 0.02.Per the instructions for use, the user is advised the following: 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.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.

Event Description

The distributor reported on behalf of the customer that the device, ts8850 concept grafix tendon stripper, 7.0mm was being used on (b)(6) 2022 during an anterior cruciate ligament reconstruction and ¿a new tendon stripper is broken at the tip during acl case.The tip felt inside the patient as per attached image 1 which made more incision to the patient and 5 hours delay¿.The procedure was completed without an alternate device.After further assessment it was found that the fragment was retrieved using a c-arm for position detection and kocher instruments.Two more incisions were made with lengths of 3 cm and 4 cm on the posterior medial femur to extract the fragment.Patient was not injured but is asking about why there are extra incision needed.No extended hospitalization was needed.This report is being raised on the basis of injury due to extra incisions to extract the fragment.

Manufacturer Narrative

Update: examination of the returned used device, item ts8850 found device tip detached from the threaded shaft.Detached tip was returned for evaluation.Evaluation was performed per print ts8850 and a55-816-100.No signs of customer misuse found during evaluation.Manufacturer narrative: the device is not being returned, but photographic evidence was provided that confirmed the reported problem.A two-year lot history review shows a total of two complaints for this lot number and failure mode.A review of the device history record from the supplier found no abnormalities that would contribute to this issue.A two-year review of complaint history revealed there has been a total of 5 reports, regarding 5 devices, for this device family and failure mode.During this same time frame 286 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 0.02.Per the instructions for use, the user is advised the following: 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.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: CONCEPT GRAFIX TENDON STRIPPER, 7.0MM
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): CLASSIC WIRE CUT CO, INC.; 25014 anza drive; valencia CA 91355
• Manufacturer (Section G): CLASSIC WIRE CUT CO, INC.; 25014 anza drive; valencia CA 91355
• Manufacturer Contact: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 15087902
• MDR Text Key: 296466016
• Report Number: 1017294-2022-00082
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: ID
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 09/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: TS8850
• Device Lot Number: 60590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 09/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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 Outcome(s): Other; Required Intervention
• Patient Age: 24 YR
• Patient Sex: Male
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic