MAUDE Adverse Event Report: COORSTEK MEDICAL 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 09/06/2017

Event Type  malfunction  

Manufacturer Narrative

Device history record review: device history record review show no non-conformances with this manufacture lot.Fatigue testing of needles from this manufacture lot shows with 95% confidence that 99.9% of the lot would pass a minimum of 24 cycles.The instructions for use included with the product caution against the use of direct force and instruct the user to use the product under direct visualization.Date product received: product was not returned.(b)(4).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 product was not returned an exact root cause could not be determined.Possible causes could be user related such as the needle contacting something hard like bone.Manufacturer error: with limited information, the device history record was reviewed and there is nothing in the record that would attribute this to an error in manufacturing.

Event Description

Champion suture passer needle broke during surgeon attempt to pass suture through rotator cuff tendon.Country of event: (b)(6).

• 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: 6916088
• MDR Text Key: 88248198
• Report Number: 3004086872-2017-00007
• 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: 10/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/31/2019
• Device Model Number: 3910-900-091
• Device Lot Number: 1203063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2017
• 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