MAUDE Adverse Event Report: CONMED INFINITY; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	KBL191
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the device kbl191, infinity anteromedial guide left 9/10 mm was being used on (b)(6) 2026 during an acl reconstruction and ¿the offset guide from the loaner set snapped in half today.'yeah the spade part popped right off while drilling the pin' from the surgeon.¿ per further assessment it was reported "the device broke in the joint while drilling the guide pin.The broken parts of the device were retrieved." there was no impact or injury to the patient or user.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
G3 initial awareness date is 13 may 2026 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.

• Brand Name: INFINITY
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): CONMED; 525 french rd; utica NY 13502
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 25390266
• Report Number: 1017294-2026-00122
• Device Sequence Number: 5205224
• Product Code: LXH
• UDI-Device Identifier: 30845854902305
• UDI-Public: (01)30845854902305(11)200227(10)1076021
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2026

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: KBL191
• Device Lot Number: 1076021
• 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: 06/30/2026
• Initial Report FDA Received Date: 06/04/2026
• Supplement Report FDA Received Date: 07/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown