MAUDE Adverse Event Report: CONMED SPECTRUM AUTOPASS SUTURE PASSER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	SMI-02AP
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device has been returned to conmed; however, the complaint investigation has not been completed.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The customer reported that the device, smi-02ap, spectrum autopass suture passer, was being used in education setting in the knee of a cadaver on (b)(6) 2024 when it was reported, ¿lower jaw broke off during regular use in a knee cadaver lab.¿ there was no report of injury, medical intervention, or hospitalization for the user.Follow up assessment questioning found that it was not known if the device fragmentation was removed from the cadaver.This report is being raised due to the reported injury of where the fragmentation was not retrieved.
Event or Problem Description
The customer reported that the device, smi-02ap, spectrum autopass suture passer, was being used in education setting in the knee of a cadaver on (b)(6) 2024 when it was reported, ¿lower jaw broke off during regular use in a knee cadaver lab.¿.There was no report of injury, medical intervention, or hospitalization for the user.Follow up assessment questioning found that it was not known if the device fragmentation was removed from the cadaver.This report is being raised due to the reported injury of where the fragmentation was not retrieved.Update: per the evaluation of the device, no parts were missing from the device; therefore, no fragmentation could remain in the cadaver.This report will be updated from injury to malfunction.
Additional Manufacturer Narrative
Update: per the evaluation of the device, no parts were missing from the device; therefore, no fragmentation could remain in the cadaver.This report will be updated from injury to malfunction.The returned used device was evaluated and found the lower jaw broken.Device did not perform as intended, failed all function test; note that both lower jaws were returned for evaluation.The root cause for this issue was not identified however, a likely cause of this issue is due to the use of excessive force.A device history record review was requested from the manufacture and no indication of abnormalities was communicated.Although this is a reusable device it is not serviceable therefore, a service history is not available for review.A two-year review of complaint history revealed there has been a total of 26 complaints, regarding 26 devices, for this device family and failure mode.During this same time frame 51,900 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 0.0005.Per the instructions for use, the user is advised the following: 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.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 mechanical shock or over stressing the instrument which may shorten the life of the instrument.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The customer reported that the device, smi-02ap, spectrum autopass suture passer, was being used in education setting in the knee of a cadaver on (b)(6) 2024 when it was reported, lower jaw broke off during regular use in a knee cadaver lab.There was no report of injury, medical intervention, or hospitalization for the user.Follow up assessment questioning found that it was not known if the device fragmentation was removed from the cadaver.This report is being raised due to the reported injury of where the fragmentation was not retrieved.Update: per the evaluation of the device, no parts were missing from the device; therefore, no fragmentation could remain in the cadaver.This report will be updated from injury to malfunction.
Additional Manufacturer Narrative
Update: d3 was updated to reflect the correct manufacturer.Update: per the evaluation of the device, no parts were missing from the device; therefore, no fragmentation could remain in the cadaver.This report will be updated from injury to malfunction.The returned used device was evaluated and found the lower jaw broken.Device did not perform as intended, failed all function test; note that both lower jaws were returned for evaluation.The root cause for this issue was not identified however, a likely cause of this issue is due to the use of excessive force.A device history record review was requested from the manufacture and no indication of abnormalities was communicated.Although this is a reusable device it is not serviceable therefore, a service history is not available for review.A two-year review of complaint history revealed there has been a total of 26 complaints, regarding 26 devices, for this device family and failure mode.During this same time frame (b)(6) 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)(6) per the instructions for use, the user is advised the following: 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.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 mechanical shock or over stressing the instrument which may shorten the life of the instrument.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: SPECTRUM AUTOPASS SUTURE PASSER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): CONMED; 525 french road; utica NY 13502
• Manufacturer (Section G): CLASSIC WIRE CUT CO, INC.; 25014 anza drive; valencia CA 91355
• Manufacturer Contact: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 19284964
• Report Number: 1017294-2024-00053
• Device Sequence Number: 8305709
• Product Code: LXH
• UDI-Device Identifier: 10845854042243
• UDI-Public: 10845854042243
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: SMI-02AP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2024
• Supplement Date Received by Manufacturer: 05/23/2024; 05/23/2024
• Initial Report FDA Received Date: 05/10/2024
• Supplement Report FDA Received Date: 06/06/2024; 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic