MAUDE Adverse Event Report: ARTHROCARE CORP. SMARTSTITCH PP CONNECTOR; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	OM-8010
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/30/2018
Type of Reportable Event	Malfunction
Additional 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.Visual inspection shows a broken/detached grasper at distal end.During the functional evaluation both needles could be extracted by using a smart stich device because the pp-connector is a single use device.The pp-connector is broken.The complaint was verified and the root cause was determined to be a mechanical component failure.Corrective action has been taken to cover this issue.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.
Event or Problem Description
It was reported that the upper part of the mouth is broken off.Breakage occurred external to patient.Procedure was completed with a s and n back up device no delay or patient injury reported.

• Brand Name: SMARTSTITCH PP CONNECTOR
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 9965572
• Report Number: 3006524618-2020-00191
• Device Sequence Number: 19018116
• Product Code: GAT
• UDI-Device Identifier: 00817470006971
• UDI-Public: 00817470006971
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K123268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/15/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: OM-8010
• Device Catalogue Number: EDOM-8010
• Device Lot Number: 1192015
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2018
• Initial Report FDA Received Date: 04/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1