MAUDE Adverse Event Report: COORSTEK MEDICAL RP 360° FLEXIBLE 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 11/08/2017

Event Type  malfunction  

Manufacturer Narrative

Device history record review shows no non-conformances associated with the manufacture lot of needles. Review also shows that sample needles from this lot were fatigue tested showing with 95% confidence that 99. 9% of the lot would pass a minimum of 24 cycles. Date product received: the product was not returned for evaluation. Device identification: 3910-900-091/h. Visual inspection: where the product was not returned a visual inspection was not performed. Functional inspection: where the 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. Manufacturing date: 12-21-2015. Root cause(s): where the device was not returned and the description of the complaint does not contain enough information, a root cause could not be determined. Manufacturer error: there is nothing in the description of the complaint and there was nothing found in the review of the device history record that would indicate this is a result of a manufacturing error. Country of event: usa.

Event Description

Rp 360 needle tip broke when being used with the champion suture passer.

• Brand Name: RP 360° FLEXIBLE 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: 7080920
• MDR Text Key: 94409819
• Report Number: 3004086872-2017-00012
• 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

• Type of Report: Initial
• Report Date: 12/04/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 12/21/2017
• Device Model Number: 3910-900-091
• Device Lot Number: 1001972
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 11/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial