MAUDE Adverse Event Report: ARTHROCARE CORP. SMARTSTITCH PP CONNECTOR; ACCESSORIES,ARTHROSCOPIC

Model Number OM-8010

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 11/09/2017

Event Type  malfunction  

Event Description

It was reported that the jaws of the device broke off during use.The broken pieces were retrieved.No patient injury or other complications were reported.

Manufacturer Narrative

The returned device, intended for use in treatment, was returned for evaluation.There was a relationship found between the device and the reported incident.Rom the information provided, the jaws of the device broke off during use.Visual inspection shows the connector was received with the s-clamp unhooked from the s-hook.Internal investigation indicates the failure cause for upper s-clamp coming loose is due to a dimensional discrepancy on the s-hook component.

• Brand Name: SMARTSTITCH PP CONNECTOR
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer Contact: jim gonzales ; 7000 w. william cannon dr.; austin, TX 78735
• MDR Report Key: 7368527
• MDR Text Key: 103699060
• Report Number: 3006524618-2018-00149
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00817470006971
• UDI-Public: (01)00817470006971(17)200131(10)1182622
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123268
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: OM-8010
• Device Catalogue Number: OM-8010
• Device Lot Number: 1182622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2018
• 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