MAUDE Adverse Event Report: ARTHROCARE CORP. SMARTSTITCH SUTURE DEVICE HANDLE; ACCESSORIES,ARTHROSCOPIC

Model Number	OM-8000
Medical Device Problem Code	Ejection Problem (4009)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/24/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery, the suture of the smartstitch would not deploy.The procedure was successfully completed without delay using a different technique.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10.H3, h6: the reported device, used in treatment, was not returned for evaluation.A relationship, if any, between the subject device and the reported event could not be determined.A review of the device history records for the device showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A review of risk management files found that the reported failure was documented appropriately.A complaint history review concluded this was a repeat issue.A review of the instructions for use found that careful attention is required for successful utilization of this device.Without the reported product a visual and functional evaluation cannot be performed and customer¿s complaint cannot be confirmed.Factors that could have contributed to the reported event include: (1) excessive force (2) tissue thickness.No containment or corrective actions are recommended at this time.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: SMARTSTITCH SUTURE DEVICE HANDLE
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10545897
• Report Number: 3006524618-2020-00784
• Device Sequence Number: 16912431
• Product Code: NBH
• UDI-Device Identifier: 00817470001679
• UDI-Public: 00817470001679
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K123268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: OM-8000
• Device Catalogue Number: OM-8000
• Device Lot Number: H107580
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/24/2020
• Supplement Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 09/17/2020
• Supplement Report FDA Received Date: 10/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention