MAUDE Adverse Event Report: CLASSIC WIRE CUT CO, INC SPECTRUM AUTOPASS SUTURE PASSER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number SMI-02AP

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/23/2023

Event Type  malfunction  

Manufacturer Narrative

The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.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 Description

The customer reported that the smi-02ap, spectrum autopass suture passer, serial number (b)(6), was being used during a shoulder ablation procedure on approximately (b)(6) 2023, and ¿the lower jaw of the spectrum suturepass cuff broke during a shoulder ablation procedure and as a result dripped into the shoulder joint.The clamp did not cause any harm to the patient when it broke, and it was removed from the shoulder joint during examination¿.The procedure was completed with an alternate same device, with no report of injury, medical intervention, or prolonged hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Reported event of lower jaw of the spectrum suture pass cuff broke during a shoulder ablation procedure and as a result dropped into the shoulder joint is confirmed.The device will not be returned for evaluation, but photographic evidence has been provided.Root cause cannot be determined, however, based upon photos and ifu; a possible cause of this event could be excessive force.Although this is a reusable device, it is not serviceable.Therefore, a service history is not available for review.A device history record review was requested from the manufacturer, and no indication of abnormalities were communicated.A two-year review of complaint history revealed there has been a total of 9 reports, regarding 9 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 (b)(4).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.Do not attempt to use a suture size other than #2 hi-fi (5 metric) or suture may not pass.Do not attempt to pass more than one strand of suture at a time or the suture may not pass.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 Description

The customer reported that the smi-02ap, spectrum autopass suture passer, serial number (b)(6), was being used during a shoulder ablation procedure on approximately (b)(6) 2023, and ¿the lower jaw of the spectrum suturepass cuff broke during a shoulder ablation procedure and as a result dripped into the shoulder joint.The clamp did not cause any harm to the patient when it broke, and it was removed from the shoulder joint during examination¿.The procedure was completed with an alternate same device, with no report of injury, medical intervention, or prolonged hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• 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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 17700323
• MDR Text Key: 322860460
• Report Number: 1017294-2023-00080
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SMI-02AP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic