MAUDE Adverse Event Report: ARTHROCARE CORP. NEEDLE AND SUTURE CAPTURE; ACCESSORIES,ARTHROSCOPIC

Catalog Number	22-4036
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/29/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a shoulder arthroscopy firstpass loaded, and the pass was not connect and broke into the patient, pieces were removed from patient.A delay of more than 30 minutes happened.Back-up device available to complete the procedure.No patient injuries reported.
Additional Manufacturer Narrative
The reported needle and suture capture device, intended for use in treatment, was returned for evaluation.A relationship between the devices and reported incident was established.From the information provided, ¿during a shoulder arthroscopy firstpass loaded, and the pass was not connect and broke into the patient, pieces were removed from patient.¿ customer¿s complaint was confirmed.Device returned were pieces #3 needle unloader, #4 suture capture trap unloader, needle and broken suture capture.The device cannot be tested as the suture capture is broken and the needle loader is not available.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: (1) incorrect suture trap loading (2) excessive force.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.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: NEEDLE AND SUTURE CAPTURE
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 9079608
• Report Number: 3006524618-2019-00455
• Device Sequence Number: 2475477
• Product Code: NBH
• UDI-Device Identifier: 00817470000184
• UDI-Public: 00817470000184
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2019

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 Expiration Date: 05/30/2022
• Device Catalogue Number: 22-4036
• Device Lot Number: 2032495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2019
• Initial Date Received by Manufacturer: 08/30/2019
• Supplement Date Received by Manufacturer: 11/01/2019
• Initial Report FDA Received Date: 09/17/2019
• Supplement Report FDA Received Date: 11/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1