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U.S. Department of Health and Human Services

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

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CONMED LARGO SPECTRUM II SUTURE HOOK, MEDIUM CRESCENT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Back to Search Results
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.
 
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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 Key18325408
MDR Text Key330489247
Report Number1017294-2023-00119
Device Sequence Number1
Product Code LXH
UDI-Device Identifier10845854031117
UDI-Public(01)10845854031117(11)210623(10)1167090
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
EXEMPT
Number of Events Reported1
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
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberC6370
Device Lot Number1167090
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/29/2023
Initial Date FDA Received12/14/2023
Supplement Dates Manufacturer Received01/29/2024
Supplement Dates FDA Received01/31/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/21/2021
Is the Device Single Use? No
Patient Sequence Number1
Patient SexMale
Patient EthnicityNon Hispanic
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