MAUDE Adverse Event Report: CLASSIC WIRE CUT CO, INC. SPECTRUM AUTOPASS SUTURE PASSER

Catalog Number SMI-02AP

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/11/2017

Event Type  malfunction  

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.

Event Description

The user facility reported that during a rotator cuff repair the spectrum autopass suture passers' jaw broke.The broken piece of the device was retrieved from the surgical site.The procedure was completed using an alternate spectrum autopass device with a 2-minute surgical delay.There was no patient injury reported.This report is raised on the basis of a reported malfunction with potential for injury with recurrence.

Manufacturer Narrative

The device was returned to conmed for evaluation.Visual inspection found the lower jaw broken with no other signs of damage.The mechanism of the device functioned as expected and there was no noticeable bend in the device's shaft.This device is a technique dependent device and the most likely cause of this suspected failure is user related or degradation over time.A review of the manufacturing documents was unable to be completed as the manufacturing documents are held by the manufacture classic wire cut co.(b)(4).The instructions for use advise the user of the following.Avoid mechanical shock or over stressing the instrument which may shorten the life of the instrument.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.To review the reported type of failure, an investigation has been initiated.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: SPECTRUM AUTOPASS SUTURE PASSER
• Type of Device: SUTURE PASSER
• Manufacturer (Section D): CLASSIC WIRE CUT CO, INC.; 28210 constellation rd.; valencia CA 91355
• Manufacturer (Section G): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• Manufacturer Contact: martha camacho urribarri ; 525 french road; utica, NY 13502-5994 ; 3156243051
• MDR Report Key: 6960814
• MDR Text Key: 90673135
• Report Number: 1017294-2017-00105
• Device Sequence Number: 1
• Product Code: HWQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2017
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 75