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

Model Number	OM-8087
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/18/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the part number om-8088 was being unpacking, it was noticed that the content did not correspond with the labeling.The box contained the following: 2 pieces of om-8085, 2 pieces of om-8087 and 2 pieces of om-8088, instead of 6 pieces of om-8088.It was also reported that the part number om-8087 had not been imported to russia before.No case or patient was involved.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, intended to be used in treatment, was not returned for evaluation.However, images of the packaging were provided.There was a relationship found between the reported incident and the returned device, based on the images provided.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 complaint history review concluded this was a repeat issue.Without the reported product a visual and functional evaluation cannot be performed; however, customer¿s complaint can be confirmed based on the images provided.The devices that were ordered did match what was received.Factors that could have contributed to the reported event include: ordering the incorrect product.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: SPEEDSTITCH SUTURE CARTRIDGE FIN
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10514035
• Report Number: 3006524618-2020-00746
• Device Sequence Number: 1178896
• Product Code: GAT
• UDI-Device Identifier: 00817470001044
• UDI-Public: 00817470001044
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K042031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2020

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 Model Number: OM-8087
• Device Catalogue Number: OM-8087
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/19/2020
• Supplement Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 09/10/2020
• Supplement Report FDA Received Date: 11/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1