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	03/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned device, intended for use in treatment, was returned for evaluation.There was no relationship found between the returned devices and the reported incident.Visual inspection shows a smart stich pp connector which was returned contaminated with bloody substances, it was used and returned with an open upper jaw with no visual damages or manufacturing abnormalities.The returned connector was inserted into a smart stich device and operates as intended without any issues.The connector was tested and deployed both needles into an om-3003 dome foam model.A suture cartridge (om-8175) was loaded and performed as specified.The right/left and both needles could be extracted as intended.The complaint was not verified.An exact root cause can/cannot be determined with confidence; however, factors that could have contributed to the reported event include: (1) not adhering to the corresponding instructions for use the used smart stich device was mechanically damaged or (2) the connector was not properly plugged (3) mechanical damages.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.The device history review and complaint history review performed for this complaint.There were no indications that would suggest that the devices did not meet product specifications upon release into distribution.
Event or Problem Description
It was reported that during surgery, the smart stich had an out of box failure, the perfect passer jaw was faulty.The procedure was completed without delay using a back-up device.No patient injury or other complications were 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: 9965883
• Report Number: 3006524618-2020-00195
• Device Sequence Number: 2092969
• Product Code: GAT
• UDI-Device Identifier: 00817470006971
• UDI-Public: 00817470006971
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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: 04/03/2020
• Device Model Number: OM-8010
• Device Catalogue Number: EDOM-8010
• Device Lot Number: 1192014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2020
• 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