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	04/24/2026
Type of Reportable Event	Malfunction
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 per regulatory requirements to help ensure patient safety.
Event or Problem Description
A sales representative reported on behalf of a customer that the ts8850, concept grafix tendon stripper, 7.0 mm device was used in an acl reconstruction procedure on (b)(6) 2026, and ¿during the harvesting of the semitendinous tendon, the instrument broke at the tip¿.The procedure was completed with the use of a mitek tendon stripper and a delay of 5 minutes.Further assessment found the device fragmented and fell into the surgical site.All fragments were retrieved using a kocher.There was no injury, medical/surgical intervention or extended hospitalization required for the patient, whose current status is reported as "all good".This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: CONCEPT GRAFIX
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): CONMED; 525 french rd; utica NY 13502
• Manufacturer (Section G): CLASSIC WIRE CUT CO, INC.; 28210 constellation road; valencia CA 91355
• Manufacturer Contact: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 25137691
• Report Number: 1017294-2026-00113
• Device Sequence Number: 13113229
• Product Code: LXH
• UDI-Device Identifier: 10845854018255
• UDI-Public: (01)10845854018255(11)250107(10)75642
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: TS8850
• Device Lot Number: 75642
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/23/2026
• Initial Report FDA Received Date: 05/11/2026
• Supplement Report FDA Received Date: 06/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/07/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown