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	09/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Visual inspection shows no discrepancies with the returned device.Functional test was performed on the returned connector and it was able to function as intended.Concomitant smart stitch device and suture cartridges were used to functionally test the connector.Foam was used to replicate tissue.The returned connector was attached to a smart stitch device and suture cartridges were used.The connector was able to clamp on a piece of foam used to replicate the tissue and was able to pass multiple stitches with no issue.The s-clamp was able to open and close with no problem and needles were able to pass single stitches and mattress stitches.No functional discrepancies were found.Based on our visual evaluation, customers complaint was not confirmed as the returned device functioned as intended.An exact root cause for failed opening and closing of the jaw cannot be determined; however, factors unrelated to the manufacture or design of the device that could have contributed to the reported event includes: (1) tissue thickness.Or (2) improper loading of the connector.Tissue thickness and/ or improper attachment of the connector on to the device handle can result in failed jaw actuation.The instruction for use (ifu) were reviewed and were 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 during surgery, the perfect passer jaw was not opening or closing properly.The procedure was completed without significant 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: 9966037
• Report Number: 3006524618-2020-00202
• Device Sequence Number: 14371551
• Product Code: GAT
• UDI-Device Identifier: 00817470006971
• UDI-Public: 00817470006971
• Combination Product (Y/N): N
• PMA/510(K) Number: K123268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• 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: 01/31/2020
• Device Model Number: OM-8010
• Device Catalogue Number: OM-8010
• Device Lot Number: 1182578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2017
• 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