MAUDE Adverse Event Report: COORSTEK MEDICAL CHAMPION PASSER NEEDLE; SUTURE PASSER NEEDLE

Model Number 3910-900-091

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/18/2017

Event Type  malfunction  

Manufacturer Narrative

Device history record review: device history record review shows no non-conformance associated with this manufacture lot of needles.Sample needles from this manufacture lot were fatigue tested and data shows with 95% confidence that 99.9% of the lot would pass a minimum of 24 cycles.Date product received: product was not returned.Device identification: 3910-900-091.Visual inspection: where product was not returned a visual inspection was not performed.Functional inspection: where product was not returned a functional inspection was not performed.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: there has been no service on this device.Root cause(s): where the device was not returned an exact root cause could not be confirmed.Where the device history record review shows no non-conformances with this manufacture lot and fatigue testing results that show with 95% confidence that 99.9% would pass a minimum of 24 cycles the root cause is most like due to something other than manufacturing.It is possible the needle came in contact with something hard, such as bone, during use.

Event Description

(b)(6), the orthopedic surgeon at the hospital sent a letter where the following event is reported: " during a surgery, when suturing a tendon, the needle broke." country of event: (b)(6).

Manufacturer Narrative

This information is provided as a follow-up to the original report because the product was returned for evaluation.The needle was returned 11-12-2017.Visual inspection of the needle shows it does not have a bend consistent with other needles that have passed through a suture passer.There are some very slight reverse bends consistent with the needle coming in contact with something hard.The exact root cause could not be determined but the reverse bending is consistent with results of a needle coming into contact with something hard.This is consistent with the original possible root cause.

• Brand Name: CHAMPION 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: 6946646
• MDR Text Key: 90247809
• Report Number: 3004086872-2017-00009
• 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,Followup
• Report Date: 10/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• 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
• Date Manufacturer Received: 09/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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: Initial
• Patient Sequence Number: 1