MAUDE Adverse Event Report: CONMED LARGO SPECTRUM II SUTURE HOOK, MEDIUM CRESCENT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number C6370

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/22/2023

Event Type  malfunction  

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.H3 other text : device not yet received.

Event Description

The sales representative reported on behalf of their customer that the c6370, spectrum ii suture hook, medium crescentwas being used on an unknown date when it was reported ¿the needle broke while it was being used, releasing a fragment into the patient.¿ we were informed that the surgeon corrected the procedure without major harm to the patient.Until now we don¿t know if another product was used to replace it, and if the time of surgery time was affected.¿.Further assessment questioning found that ¿the tip of the instrument broke inside the patient's joint.It was recovered.The broken tip was removed with grasper forceps".¿ the procedure was completed, and the current status of the patient was reported as ¿he is well.Recovering from the procedure.¿.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.(b)(4).Per the instructions for use, the user is advised 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.Do not use if parts are broken, cracked or worn, or device function may be compromised.There is an increased risk of hook or needle breakage and unintentional patient injury may result.Do not exceed five procedures per limited reuse suture hook.Do not use disposable suture hook for more than one procedure.The information obtained does not reasonably suggest that the device has or may have caused or contributed to a death, serious injury, or has malfunctioned in a manner that would be likely to cause or contribute to a death or serious injury if it were to recur.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

The sales representative reported on behalf of their customer that the c6370, spectrum ii suture hook, medium crescentwas being used on an unknown date when it was reported ¿the needle broke while it was being used, releasing a fragment into the patient." we were informed that the surgeon corrected the procedure without major harm to the patient.Until now we don¿t know if another product was used to replace it, and if the time of surgery time was affected." further assessment questioning found that ¿the tip of the instrument broke inside the patient's joint.It was recovered.The broken tip was removed with grasper forceps." the procedure was completed, and the current status of the patient was reported as ¿he is well.Recovering from the procedure." this report is being raised on the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: SPECTRUM II SUTURE HOOK, MEDIUM CRESCENT
• Type of Device: 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: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 18325408
• MDR Text Key: 330489247
• Report Number: 1017294-2023-00119
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10845854031117
• UDI-Public: (01)10845854031117(11)210623(10)1167090
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C6370
• Device Lot Number: 1167090
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2021
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic