MAUDE Adverse Event Report: ARTHROCARE CORP. FIRSTPASS MINI RIGHT; ACCESSORIES,ARTHROSCOPIC

Model Number 72290130

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/22/2020

Event Type  malfunction  

Event Description

It was reported that during procedure, the upper jaw on the suture passer was not catching the suture properly when passing through tissue in the shoulder.No significant delay and it is unknown how the procedure was completed.No other complication were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Event Description

It was reported that during shoulder procedure, the upper jaw on the suture passer was not catching the suture properly when passing through tissue in the shoulder.No significant delay and it is unknown how the procedure was completed.No other complication were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10, b5, 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 2030309 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: excessive force; tissue thickness; damage or debris on 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: FIRSTPASS MINI RIGHT
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10162310
• MDR Text Key: 195393088
• Report Number: 3006524618-2020-00387
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00885556694572
• UDI-Public: 00885556694572
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/31/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 03/11/2022
• Device Model Number: 72290130
• Device Catalogue Number: 72290130
• Device Lot Number: 2030309
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/22/2020
• Initial Date FDA Received: 06/17/2020
• Supplement Dates Manufacturer Received: 07/29/2020
• Supplement Dates FDA Received: 07/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1