MAUDE Adverse Event Report: COORSTEK MEDICAL SUTURE PASSER NEEDLE BOX OF 5

Model Number 3910-900-091

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/01/2017

Event Type  malfunction  

Manufacturer Narrative

Device history record review: device history record review showed no non-conformances associated with this manufacture lot.Fatigue test certifications show with 95% confidence that 99% of this manufacture lot of needles will pass a minimum of 24 cycles.This failure mode 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.Root cause(s):.Where the product was not returned for evaluation and the incident comments do not contain any details an exact root cause could not be determined.A possible cause could be use of the product in a manner other than described in the instructions for use included with the product.

Event Description

The customer reported that the needle broken during use a portion of the needle remains in the patient.Location of event: (b)(6).

• Brand Name: SUTURE PASSER NEEDLE BOX OF 5
• 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: 6874656
• MDR Text Key: 87320769
• Report Number: 3004086872-2017-00006
• 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: 09/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/20/2019
• Device Model Number: 3910-900-091
• Device Lot Number: 1270136
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/05/2017
• Initial Date FDA Received: 09/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1