MAUDE Adverse Event Report: ARTHROCARE CORP. DFP SUTURE PASSER, STANDARD

Catalog Number	22-4039
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/19/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a shoulder surgery, the firstpass suture passer was faulty, it had both jaws closed and would not open.The procedure was successfully completed without significant delay using a back-up device.No patient injuries or 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 device reported, used in treatment, was not returned for evaluation.A relationship between the product and reported incident cannot be established.A review of manufacturing records for the reported lot number 2047482 found no non-conformances or anomalies during manufacturing process related to the reported event.A visual inspection and functional evaluation cannot be performed and customer´s complaint cannot be confirmed.Potential factors unrelated to the design or manufacture of the device that may lead to the failure reported include, but are not limited to: (1) excessive force (2) tissue thickness.(3) damage or debris in the device tip between passes.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: DFP SUTURE PASSER, STANDARD
• Common Device Name: PASSER
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10262190
• Report Number: 3006524618-2020-00472
• Device Sequence Number: 11494650
• Product Code: HWQ
• UDI-Device Identifier: 00885556724552
• UDI-Public: 885556724552
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 08/25/2020

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: 01/11/2023
• Device Catalogue Number: 22-4039
• Device Lot Number: 2047482
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/19/2020
• Supplement Date Received by Manufacturer: 08/24/2020
• Initial Report FDA Received Date: 07/12/2020
• Supplement Report FDA Received Date: 08/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1