MAUDE Adverse Event Report: CONMED LARGO SPECTRUM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	C6369
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the device, c6369, spectrum ii suture hook, small crescent was being used on (b)(6) 2025 during a knee arthroscopy for meniscus suture and "use of the spectrum hook (conmed).4th use (previously on (b)(6) 2025; (b)(6) 2025; (b)(6) 2025).The right hook broke inside the joint during the procedure without the surgeon forcing it.The piece of metal was recovered and did not remain in the patient's knee.¿ 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
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.
Additional Manufacturer Narrative
The evaluation of returned used device c6369 found the hook broken off and detached from shaft.Root cause cannot be determined, however, based upon evaluation of the device and the ifu; a possible cause of this event could be excessive lateral stress.A two-year lot history review shows a total of one device for this lot number and failure mode.A device history record review found no abnormalities that would contribute to this reported event.A two-year review of complaint history revealed there has been a total of (b)(4) reports, regarding (b)(4) devices, for this device family and failure mode.During this same time frame (b)(4) 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 (b)(4).Per the instructions for use, the user is advised the following: if the hook or needle bends during use, immediately discontinue use and discard.There is an increased risk of hook or needle breakage and unintentional patient injury may result.Avoid lateral stresses to the instruments or device function may be compromised.There is an increased risk of hook or needle breakage and unintentional patient injury may result we will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The customer reported that the device, c6369, spectrum ii suture hook, small crescent was being used on (b)(6) 2025 during a knee arthroscopy for meniscus suture and "use of the spectrum hook (conmed).4th use (previously on 0(b)(6) 2025; (b)(6) 2025; (b)(6) 2025).The right hook broke inside the joint during the procedure without the surgeon forcing it.The piece of metal was recovered and did not remain in the patient's knee.¿ 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.

• Brand Name: SPECTRUM
• Common Device Name: 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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 23141970
• Report Number: 1017294-2025-00104
• Device Sequence Number: 15910492
• Product Code: LXH
• UDI-Device Identifier: 10845854031100
• UDI-Public: (01)10845854031100(11)250227(10)1443052
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2025

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: C6369
• Device Lot Number: 1443052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2025
• Supplement Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 09/25/2025
• Supplement Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic