MAUDE Adverse Event Report: COORSTEK MEDICAL SUTURE PASSER NEEDLE

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.

• 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: 7035640
• MDR Text Key: 93220103
• Report Number: 3004086872-2017-00011
• 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: 11/15/2017

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: Physician
• Device Expiration Date: 06/06/2019
• Device Model Number: 3910-900-091
• Device Lot Number: 1251584
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/25/2017
• Initial Date FDA Received: 11/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2017
• 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