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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COORSTEK MEDICAL SUTURE PASSER NEEDLE

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COORSTEK MEDICAL SUTURE PASSER NEEDLE Back to Search Results
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).
 
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Brand NameSUTURE PASSER NEEDLE
Type of DeviceSUTURE 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 Key6443023
MDR Text Key71324764
Report Number3004086872-2017-00001
Device Sequence Number1
Product Code GAB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 03/27/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/29/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2017
Device Model Number3910-900-091
Device Lot Number1001973
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/09/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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