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	01/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported smart stitch pp connector, intended for use in treatment, was returned for evaluation.It was reported that while preparing for the application while loading the suture, the device failed and the tip fell off.A relationship between the device and reported incident was established.Visual evaluation shows the device with a broken/detached grasper at distal end and loaded with an empty suture cartridge.The connector was received with the s-clamp unhooked from the s-hook.The grasper (s-clamp) was returned.During functional evaluation the connector was successfully adapted in to a smart stitch device (om-8000) and operates as intended.Further functional tests were not possible due to the damage of the connector.Internal investigation indicates the failure cause for upper s-clamp coming loose or breaking is due to a dimensional discrepancy on the s-hook component.Changes to the component have been implemented to prevent this failure.The instruction for use was reviewed and found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.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 while preparing for the application while loading the suture, the device failed and the tip fell off.

• 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: 9965541
• Report Number: 3006524618-2020-00190
• Device Sequence Number: 10948124
• Product Code: GAT
• UDI-Device Identifier: 00817470006971
• UDI-Public: 00817470006971
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K123268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• 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 Model Number: OM-8010
• Device Catalogue Number: EDOM-8010
• Device Lot Number: 2006017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2018
• 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