MAUDE Adverse Event Report: CONMED CONCEPT GRAFIX; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	TS8850
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2024
Type of Reportable Event	Serious Injury
Additional 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.We will continue to monitor for trends through the complaint system to assure patient safety.Device not yet received.
Event or Problem Description
The distributor reported on behalf of their customer that the device, ts8850, concept grafix tendon stripper, 7.0 mm, was being used during an acl procedure on (b)(6) 2024 when it was reported, ¿the tip of this ts8850 was broken during graft cutting.¿.Further reporting states, ¿more incision to take out the broken tip.¿ the procedure was completed with another tendon stripper.More incision was required to remove the tip.There was no report of extended hospitalization for the patient.This report is being raised due to the reported injury of ¿more incision¿ required to retrieve tip.
Event or Problem Description
The distributor reported on behalf of their customer that the device, ts8850, concept grafix tendon stripper, 7.0 mm, was being used during an acl procedure on (b)(6) 2024 when it was reported, ¿the tip of this ts8850 was broken during graft cutting.¿.Further reporting states, ¿more incision to take out the broken tip.¿ the procedure was completed with another tendon stripper.More incision was required to remove the tip.There was no report of extended hospitalization for the patient.This report is being raised due to the reported injury of ¿more incision¿ required to retrieve tip.
Additional Manufacturer Narrative
Examination of the returned used device, item ts8850 found tendon stripper tip broken off from the shaft.The broken tip was not returned for evaluation.The root cause cannot be determined, however, based upon evaluation, photo and an adverse event review meeting, the likely cause of this event was excessive force.A device history review (dhr) was requested from the manufacturer, and no indication of abnormalities was communicated.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 372 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 0.003.We will continue to monitor for trends through the complaint system to assure patient safety.
Additional Manufacturer Narrative
Update: d3 was updated to reflect the correct manufacturer.Examination of the returned used device, item ts8850 found tendon stripper tip broken off from the shaft.The broken tip was not returned for evaluation.The root cause cannot be determined, however, based upon evaluation, photo and an adverse event review meeting, the likely cause of this event was excessive force.A device history review (dhr) was requested from the manufacturer, and no indication of abnormalities was communicated.This is the only complaint for this lot number and failure mode within the past two years.(b)(4).We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The distributor reported on behalf of their customer that the device, ts8850, concept grafix tendon stripper, 7.0 mm, was being used during an acl procedure on (b)(6) 2024 when it was reported, ¿the tip of this ts8850 was broken during graft cutting.¿.Further reporting states, ¿more incision to take out the broken tip.¿ the procedure was completed with another tendon stripper.More incision was required to remove the tip.There was no report of extended hospitalization for the patient.This report is being raised due to the reported injury of ¿more incision¿ required to retrieve tip.

• Brand Name: CONCEPT GRAFIX
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): CONMED; 525 french road; utica NY 13502
• Manufacturer (Section G): CLASSIC WIRE CUT CO, INC.; 25014 anza drive; valencia CA 91355
• Manufacturer Contact: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 20733158
• Report Number: 1017294-2024-00135
• Device Sequence Number: 8949610
• Product Code: LXH
• UDI-Device Identifier: 10845854018255
• UDI-Public: 10845854018255
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/27/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: TS8850
• Device Lot Number: 72331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2024
• Supplement Date Received by Manufacturer: 12/20/2024; 12/20/2024
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 01/16/2025; 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic