MAUDE Adverse Event Report: ARTHROCARE CORP. SPEEDSTITCH DEVICE; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	OM-7000
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/19/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there is an issue with the device, the lever is not closing and opening.No patient injuries or delay were reported.Procedure was finished with a competitor device.
Additional Manufacturer Narrative
The reported speedstitch device, intended for use in treatment, was returned for evaluation.A relationship between the device and reported incident was not established.From the information provided, ¿the lever is not closing and opening.¿ customer¿s complaint was not confirmed.Visual evaluation shows the device with tooling marks on the barrel windows and clamp tube.Functional test was performed on the returned device and the device was able to function as expected.A needle and suture cartridge were used for functional test.The device was able to take in the needle and suture cartridge with no issues.The needle was fired thru foam used to replicate tissue and was able to capture and pass a stitch with no problem.The needle and clamp levers actuated as intended.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: (1) normal wear and tear.(2) excessive force (3) incorrect needle loading/ unloading technique and tools which can result in damaged handle.Careful attention should be made to assure that excessive force is not placed on this instrument.Always actuate the speedstitch suturing device without a suture cartridge prior to clinical use.This will ensure that the tissue jaw lever, ratchet release button, and needle driver lever are functioning properly.Repeated processing of this instrument has minimal effect on product lifetime and function.Visible deterioration such as corrosion or damage resulting from wear and tear or handling is cause for retirement of the instrument from further use.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: SPEEDSTITCH DEVICE
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 8410136
• Report Number: 3006524618-2019-00137
• Device Sequence Number: 1473571
• Product Code: GAT
• UDI-Device Identifier: 00817470001402
• UDI-Public: 00817470001402
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2019

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 Catalogue Number: OM-7000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/19/2019
• Supplement Date Received by Manufacturer: 05/06/2019
• Initial Report FDA Received Date: 03/11/2019
• Supplement Report FDA Received Date: 05/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1