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

Catalog Number	SMI-02N
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A distributor reported on behalf of a customer that the smi-02n, spectrum autopass suture passer needle device was used in a rotator cuff repair procedure on (b)(6) 2026, and ¿the needle became jammed and broke inside the patient.¿.The procedure was completed with the use of an alternate same device.Further assessment found ¿the needle fragmented inside the patient, but the fragments were removed using hospital instruments.¿.There was no report of injury, medical/surgical intervention or extended hospitalization required for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Reported event of needle became jammed and broke inside the patient¿ fragments were removed is confirmed.The device will not be returned for evaluation; however, video evidence has been provided.Root cause cannot be determined, however, based upon ifu; a possible cause of this event could be that the needle kinked.A two-year lot history review shows a total of 1 device for this lot number and failure mode.A device history record (dhr) review was requested from the manufacturer, and no indication of abnormalities was communicated.A two-year review of complaint history revealed there has been a total of four reports, regarding eight devices, for this device family and failure mode.During this same time frame 56,417 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 0.0001.Per the instructions for use, the user is advised that if the suture passer needle kinks during use, immediately discontinue use and discard.There is an increased risk of needle breakage and unintentional patient injury may result.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 rd; utica NY 13502
• Manufacturer (Section G): CLASSIC WIRE CUT CO, INC.; 28210 constellation road; valencia CA 91355
• Manufacturer Contact: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 24638964
• Report Number: 1320894-2026-00064
• Device Sequence Number: 9918711
• Product Code: LXH
• UDI-Device Identifier: 10845854045756
• UDI-Public: (01)10845854045756(17)300707(10)77193
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/19/2026

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-02N
• Device Lot Number: 77193
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic