MAUDE Adverse Event Report: COORSTEK MEDICAL SUTURE PASSER NEEDLE

Model Number 3910-900-091

Device Problems Material Fragmentation (1261); Improper or Incorrect Procedure or Method (2017)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/31/2017

Event Type  malfunction  

Manufacturer Narrative

Visual inspection: product is not returning so visual inspection was not performed.Functional inspection: product is not returning so functional testing was not performed.Additional investigation notes: the device history record for this manufacture lot showed no non-conformance during manufacture.The instructions for use included with the product specify it is designed to pass, "usp #2 braided surgical suture".It is possible trying to pass labral tape as described in the alleged problem is a root cause to the needle tip breaking.The surgeon used the needle approximately 10 times which exceeded the normal cycling frequency of 6 times.This could also be a contributing root cause to the needle breaking.Where the product was not returned an exact root cause could not be determined.Service history review: there has been no service with this product.Root cause(s): use of the suture passer in a manner other than described in the instructions for use included with the product.Product was not returned to manufacturer.

Event Description

The surgeon was passing labral tape during a rotator cuff repair procedure using the champion suture passer.The surgeon used the passer approximately 10 times without an issue.He then said it had 'stopped working".Upon inspection, the tip of the rp360 flexible needle was missing.The surgeon said it was in the patients tissue and could not be retrieved.The operation was completed using a competitor product.Country of event: (b)(6).

• Brand Name: SUTURE PASSER NEEDLE
• Type of Device: SUTURE PASSER NEEDLE
• Manufacturer (Section D): COORSTEK MEDICAL; 867 west 400 north; logan UT 84321
• Manufacturer (Section G): COORSTEK MEDICAL; 867 west 400 north; logan UT 84321
• Manufacturer Contact: robert bates ; 867 west 400 north; logan, UT 84321 ; 4357741500
• MDR Report Key: 6443023
• MDR Text Key: 71324764
• Report Number: 3004086872-2017-00001
• Device Sequence Number: 1
• Product Code: GAB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/31/2017
• Device Model Number: 3910-900-091
• Device Lot Number: 1001973
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1