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

Catalog Number SMI-02AP

Device Problems Bent (1059); Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/18/2018

Event Type  malfunction  

Manufacturer Narrative

The returned, used device was evaluated and it was found that the upper jaw is broken and still attached to the shaft.The trap door is broken and does not close.The lower jaw has been slightly bent.Device failed all functional tests.Suspect that the returned device may have been damaged during surgical process due to the lower jaw being slightly bent.The service history for this device was reviewed and no data was found.A two-year review of complaint history revealed there has been a total of 27 complaints, regarding 27 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: contraindications: device is not to be used on bone or similar hard tissue.Warnings: 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.Whether used arthroscopically or in open surgery the suture passer must be used under direct visualization.Precautions: 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.

Event Description

This distributor reported that the smi-02ap, spectrum autopass suture passer, made a cracking sound during use in a rotator cuff procedure on (b)(6) 2018.There was no report of fragmentation or loose component of the device.There was no report of lost component within the patient; therefore, there was no need for retrieval.It was reported that there was a 5-minute delay in procedure; however, another "clamp" was used to complete the procedure.There was no report of medical intervention being required or extended hospital stay.It was reported that there was no user or patient impact due to this event.This report is being raised as a device malfunction with the potential for injury with reoccurrence.

• Brand Name: SPECTRUM AUTOPASS SUTURE PASSER
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED CORPORATION; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 7523117
• MDR Text Key: 109007166
• Report Number: 1017294-2018-00064
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/17/2018

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
• Device Operator: Physician
• Device Catalogue Number: SMI-02AP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/24/2018
• Initial Date FDA Received: 05/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR