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	08/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The reported smart stitch pp-connector was not returned for evaluation and the device was intended for treatment.A relationship between the reported connector and reported incident could not be established due to product not being returned.Visual and functional testing of the subject device could not be performed since the subject device was not returned for evaluation; therefore, the complaint could not be verified and a root cause could not be determined with confidence.Factors unrelated to the manufacture or design of the device that could have contributed to the reported event include: incorrect load of the connector to the device handle.The instruction for use outlines warnings and precautionary measures when using the device such as: - ensure that the connector is completely seated in the handle before removing the tip protector.- always actuate the suturing device without a suture cartridge prior to clinical use.This will ensure that the clamp jaw lever, connector release lever, and needle driver lever are functioning properly.- if the suturing device does not function properly and smoothly, immediately discontinue use and contact an authorized customer service representative.An exact root cause cannot be determined with confidence without the reported smart stitch perfect passer connector.The instruction for use was reviewed and found the following warning and precautionary statements: 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 jaws did not close after inserting into cuff.It is unknown if there was a delay in the procedure.A back up device was available and no patient injuries 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: 9966038
• Report Number: 3006524618-2020-00203
• Device Sequence Number: 3676280
• Product Code: GAT
• UDI-Device Identifier: 00817470006971
• UDI-Public: 00817470006971
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Physician
• 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: 12/31/2019
• Device Model Number: OM-8010
• Device Catalogue Number: OM-8010
• Device Lot Number: 1178578
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2017
• 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