MAUDE Adverse Event Report: CONMED SPECTRUM AUTOPASS; 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	12/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the device, smi-02ap, spectrum autopass suture passer, was being used during an unknown procedure on (b)(6) 2024 when it was reported, ¿the instrument broke during intraoperative cuff suture.¿.There was no report of injury, medical intervention, or hospitalization for the patient or the user.The photographic evidence from the reporter shows the broken piece of the device.The procedure was completed with an alternate device causing a 10-minute delay in the procedure.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.H3 other text: device not yet received.
Event or Problem Description
The customer reported that the device, smi-02ap, spectrum autopass suture passer, was being used during an unknown procedure on (b)(6)2024 when it was reported, ¿the instrument broke during intraoperative cuff suture.¿.There was no report of injury, medical intervention, or hospitalization for the patient or the user.The photographic evidence from the reporter shows the broken piece of the device.The procedure was completed with an alternate device causing a 10-minute delay in the procedure.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The returned used device, item smi-02ap was evaluated for spsmi-02ap, rev-ac and (b)(4), rev-ac found broken lower jaw.A root cause cannot be determined; however, based upon evaluation of the device, a possible cause of this event could be that there was use of excessive force.A device history record (dhr) review was requested from the manufacturer, and no indication of abnormalities was communicated.A two-year lot history review shows a total of 1 device for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 22 complaints, regarding 22 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 0.0004.Per the instructions for use, the user is advised to avoid lateral stresses to the instrument or device function maybe compromised.Do not use if parts are broken, cracked or worn, or device function maybe 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.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The customer reported that the device, smi-02ap, spectrum autopass suture passer, was being used during an unknown procedure on (b)(6) 2024 when it was reported, "the instrument broke during intraoperative cuff suture." there was no report of injury, medical intervention, or hospitalization for the patient or the user.The photographic evidence from the reporter shows the broken piece of the device.The procedure was completed with an alternate device causing a 10-minute delay in the procedure.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Update: d3 was updated to reflect the correct manufacturer.The returned used device, item smi-02ap was evaluated for spsmi-02ap, rev-ac and ip-000-998, rev-ac found broken lower jaw.A root cause cannot be determined; however, based upon evaluation of the device, a possible cause of this event could be that there was use of excessive force.A device history record (dhr) review was requested from the manufacturer, and no indication of abnormalities was communicated.A two-year lot history review shows a total of 1 device for this lot number and failure mode.(b)(4).Per the instructions for use, the user is advised to avoid lateral stresses to the instrument or device function maybe compromised.Do not use if parts are broken, cracked or worn, or device function maybe 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.We will continue to monitor per regulatory requirements to help ensure patient safety.

• Brand Name: SPECTRUM AUTOPASS
• 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: 20950475
• Report Number: 1017294-2024-00160
• Device Sequence Number: 7674856
• Product Code: LXH
• UDI-Device Identifier: 10845854042243
• UDI-Public: 10845854042243
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/26/2026

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: SMI-02AP
• 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: 12/03/2024
• Supplement Date Received by Manufacturer: 01/31/2025; 01/31/2025
• Initial Report FDA Received Date: 12/17/2024
• Supplement Report FDA Received Date: 02/05/2025; 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic