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

Catalog Number SMI-02D

Device Problems Break (1069); Entrapment of Device (1212); Material Fragmentation (1261); Device Or Device Fragments Location Unknown (2590)

Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)

Event Date 03/08/2017

Event Type  malfunction  

Manufacturer Narrative

As reported, the spectrum autopass needle is expected to be returned for evaluation.However, as of this filing, the "used/damaged" needle has not yet been returned from the user facility.A supplemental and final report will be filed upon the completion of the device evaluation and the complaint investigation.

Event Description

The user facility reported that during use of the spectrum autopass needle with a spectrum autopass suture passer in a shoulder arthroscopy procedure on (b)(6) 2017, the tip of the needle broke off in the surgical site.As reported, the breakage occurred during the fifth or sixth pass of the needle through the tendon.Attempt to retrieve the tiny broken fragment failed, as the fragment could not be located or retrieved.Other than a delay of approximately 15-20 minutes, the procedure was otherwise completed with no further complications or serious injury to the patient.This report is filed on the basic of potential for patient injury with recurrence.

Manufacturer Narrative

One (1) used spectrum autopass needle was returned to conmed for evaluation on 11-may-2017.Visual examination found the tip of the needle was broken off and the tiny broken tip approximately 1.52mm was not returned.Further examination of the needle found evidence of misuse due to needle bending.Based on the evaluation finding, it is believed that the most probable cause of the reported needle tip breakage was use related.This lot #33954 was manufactured on 24-nov-2015.Of the lot containing 2,020 units, there have been 2 other similar complaints received for this item and lot number combination.A 2-year review of complaint history shows there have been a total of 44 reports of tip breakage with a quantity of 45 units, including this one.During this same time frame, approximately (b)(4) units have been sold worldwide, making the rate of occurrence for this failure mode 0.(b)(4).To date, there have been no patient long term adverse effects resulting from this type of incidents.The use of the autopass suture passer and needle is very technique dependent.This failure mode is addressed in the dfmea and the risk analysis has been deemed acceptable.The needle shaft and blade are made of 96se508 super elastic nitinol.A material routinely used in the manufacture of medical instruments with a long history of safe and effective clinical use.Nitinol is used in vascular stents, valve patches and orthodontic devices.To reduce the risk of needle breakage and patient injury, the information for use (ifu) provides the user with the following 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.If tissue is excessively thick or rolled and suture passer jaws do not close far enough there is a chance of suture passer needle missing the window of the suture retrieval mechanism.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.Do not use disposable suture passer needle for more than one (1) procedure.Reuse could cause fatigue and/ or breakage of the needle, which may cause possible patient injury.

• Brand Name: SPECTRUM AUTOPASS NEEDLE
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• Manufacturer (Section G): CONMED CORPORATION; 11311 concept boulevard; largo FL 33773
• Manufacturer Contact: n. kim grady ; 11311 concept boulevard; largo, FL 33773 ; 7273995479
• MDR Report Key: 6437228
• MDR Text Key: 71219211
• Report Number: 1017294-2017-00028
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/24/2017
• Device Catalogue Number: SMI-02D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: SPECTRUM SUTURE PASSER, SMI-02AP SERIAL #: UNK
• Patient Age: 68 YR
• Patient Weight: 60