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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CLASSIC WIRE CUT CO, INC. SPECTRUM AUTOPASS SUTURE PASSER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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CLASSIC WIRE CUT CO, INC. SPECTRUM AUTOPASS SUTURE PASSER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Back to Search Results
Catalog Number SMI-02AP
Device Problem Component Missing (2306)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
The customer reported that the device, smi-02ap, spectrum autopass suture passer was found during pre-operative testing on an unknown date when it was reported that ¿the lower jaw clamping device is missing.¿ there was no report of injury, medical intervention, or hospitalization for the patient.There was no report of device fragmentation.There was no report if the procedure was completed, if an alternate device was used to complete the surgery, or if there was any delay to the surgery.A good faith effort attempt was completed for further assessment information; however, no response was received from the reporter to date.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
 
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.This issue will continue to be monitored through the complaint system to assure patient safety.Device not yet received.
 
Manufacturer Narrative
The device has not been returned to date and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.Although this is a reusable device, it is not serviceable.Therefore, a service history is not available for review.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.A device history record review performed by the vendor found a quantity of (b)(4) units were manufactured and no abnormalities were noted.A two-year review of complaint history revealed there has been a total of 13 complaints, regarding 13 devices, for this device family and failure mode.During this same time frame 44,120 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 0.0003.Per the instructions for use, the user is advised to that prior to use, inspect instrument to ensure it is in good physical condition and functions properly.There should be no loose, broken or misaligned parts.Avoid lateral stresses to the instrument or device function may be compromised.Do not use if parts are broken, cracked or worn, or device function may be compromised.This issue will continue to be monitored through the complaint system to assure patient safety.
 
Event Description
The customer reported that the device, smi-02ap, spectrum autopass suture passer was found during pre-operative testing on an unknown date when it was reported that ¿the lower jaw clamping device is missing.¿ there was no report of injury, medical intervention, or hospitalization for the patient.There was no report of device fragmentation.There was no report if the procedure was completed, if an alternate device was used to complete the surgery, or if there was any delay to the surgery.A good faith effort attempt was completed for further assessment information; however, no response was received from the reporter to date.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
 
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Brand Name
SPECTRUM AUTOPASS SUTURE PASSER
Type of Device
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Manufacturer (Section D)
CLASSIC WIRE CUT CO, INC.
25014 anza drive
valencia CA 91355
Manufacturer (Section G)
CLASSIC WIRE CUT CO, INC.
25014 anza drive
valencia CA 91355
Manufacturer Contact
courtney pomichter
525 french rd
utica, NY 13502
3156243170
MDR Report Key14654574
MDR Text Key301469354
Report Number1017294-2022-00070
Device Sequence Number1
Product Code LXH
Combination Product (y/n)N
Reporter Country CodeAR
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberSMI-02AP
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received07/12/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/16/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient EthnicityNon Hispanic
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