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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 Problem Material Fragmentation (1261)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 10/20/2017
Event Type  malfunction  
Manufacturer Narrative
Device history record review: device history record review shows no non-conformances with this manufacture lot. The record shows that sample needles from this manufacture lot were fatigue tested showing with 95% confidence that 100% of the needles will pass a minimum of 24 cycles. Date product received: 11-13-2017. Device identification: 3910-900-091. Visual inspection: the returned needle was visually inspected and it was confirmed the tip of the needle was broken off. There were no indications the breakage was a result of a manufacturing error. An exact root cause of the breakage could not be determined. Functional inspection: where the needle tip was already broken a functional inspection was not performed. Additional investigation notes: a request for additional information regarding the complaint found the needle was being passed through a "very thick cuff" at the time of breakage. This is the only evidence found that may possibly be the root cause of the breakage. This is a known failure mode addressed in the risk management file for this product, and does not exceed expected occurrence rates. Occurrence rates are monitored for trends. Service history review: the needle is labeled as one time use so there has been no service on this product. Manufacturing date: 6-6-2017. Root cause(s): a possible cause of the breakage is the needle was being passed through a "very thick cuff" at the time of breakage. (b)(6).
 
Event Description
The customer reported that the needle tip of the champion suture passer broke. The surgeon searched for the needle tip but was unable to find it. The customer further reported that the patient was x-ray at the end of the procedure and the tip of the passer needle appeared to be buried in the cuff and was irretrievable.
 
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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 Key7035640
MDR Text Key93220103
Report Number3004086872-2017-00011
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 11/15/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/15/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/06/2019
Device Model Number3910-900-091
Device Lot Number1251584
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/12/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/25/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/06/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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