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

Catalog Number	OM-7000
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was not working during a procedure.There was no delay or patient injuries but, it is unknown how the procedure was finished since no backup device was available to complete it.Attempts were made to retrieve further information but no response has been received from the complainant.
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 established.From the information provided, ¿device was not working during a procedure.¿ customer¿s complaint was confirmed.Visual evaluation shows the device handle missing one screw and the spring is coming out of the silver clamp lever.The barrel is completely loose, not attached to the handle.Functional evaluation is not possible due to the device severe damage.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: (1) excessive force (2) expected wear and tear.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 instruction for use states: as with any surgical instrument, careful attention should be made to assure that excessive force is not placed on this instrument.Excessive force can result in failure.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: 8814499
• Report Number: 3006524618-2019-00345
• Device Sequence Number: 2859861
• Product Code: GAT
• UDI-Device Identifier: 00817470001402
• UDI-Public: 00817470001402
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K042031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2019

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
• Device Lot Number: H971700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Initial Date Received by Manufacturer: 07/01/2019
• Supplement Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 07/22/2019
• Supplement Report FDA Received Date: 08/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1