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

Catalog Number SMI-02D

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/25/2015

Event Type  No Answer Provided  

Manufacturer Narrative

The involved spectrum autopass suture passer needle is not expected for evaluation as it was discarded at the user facility.Without the actual product, an evaluation could not be performed and the root cause of the reported needle breakage was not able to be determined.This lot with the (b)(4) was manufactured on 31-aug-2015 in a lot of (b)(4) units.There has been one other similar complaint received for this item and lot number combination.A 2-year review of complaint history shows there have been fifteen (15) other similar complaints received for this product.During this same time frame, approximately (b)(4) units have been sold worldwide, making the rate of occurrence for this failure mode (b)(4) to date, there have been no patient long term adverse effects reported regarding any of the reported incidents.This failure mode is addressed in the dfmea, and the safety risk has been found to be acceptable.The suture passer and needle were released in (b)(6) 2014 and the use of this product is technique dependent.The risk analysis has been deemed acceptable per new product quality engineer monitoring.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.Device was discarded at user facility.

Event Description

The customer reported that during use of the spectrum autopass suture passer needle with a spectrum autopass suture passer in a shoulder arthroscopy rotator cuff repair procedure, the surgeon had difficulty passing the suture through the tissue on the fourth pass.During which time, the surgeon noticed that the tip of the nitinol spectrum autopass needle had broken off and was missing.The surgeon physically searched for the tiny broken tip in the surgical site, but was unable to locate it.The surgeon then used the suction of a shaver blade (typically used in this type of procedure) in attempt to remove the broken tip.A second needle was used and the procedure was completed with no further complications or patient injury.To date, there has been no additional information received regarding the patient's latest condition or any indication that a long term adverse effect has occurred.

• Brand Name: SPECTRUM AUTOPASS SUTURE PASSER NEEDLE
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): CONMED LINVATEC; 11311 concept blvd.; largo FL 33773
• Manufacturer (Section G): CONMED LINVATEC; 11311 concept blvd.; largo FL 33773
• Manufacturer Contact: brenda johnson ; 11311 concept blvd.; largo, FL 33773 ; 7273995515
• MDR Report Key: 5303948
• MDR Text Key: 33717658
• Report Number: 1017294-2015-00084
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: SMI-02D
• Device Lot Number: 33414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Weight: 110