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

Model Number	NEEDLE AND SUTURE CAPTURE
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/15/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a shoulder arthroscopy, the tip of the needle and suture capture cracked and the jaw could not open, causing the device to not catch the suture.The procedure was successfully completed without significant delay using a back-up device.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: d10, h2, h3, h6 the firstpass suture passer device, used in treatment, was returned for evaluation.A relationship between the device and reported incident was not established.A review of manufacturing records for the reported lot number k5001z found no non-conformance's or anomalies during manufacturing process related to the reported event.A complaint history review found related failures; this failure mode will be trended to assess for any necessary corrective actions.Review of the product instructions for use found adequate warnings and precautions to prevent damage to the device during use.Risk management documents were reviewed finding no additional risks that require to be added to the reference document.Clinical evaluation was completed and concluded that based on the information provided, a backup device finished the procedure and there was no impact/ injury to the patient reported as result of the reported event.Should additional medical information, be provided this complaint will be re-assessed.Visual evaluation shows pieces of tape over the device handle.The upper jaw is slightly loose and misaligned.No manufacturing discrepancies observed.During functional test, it was an unsuccessful attempt to load a needle into the device.The needle could not engage and deploy a stitch.The complaint is not verified as the jaws open and close.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.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: 10123135
• Report Number: 3006524618-2020-00328
• Device Sequence Number: 14223781
• Product Code: NBH
• UDI-Device Identifier: 00817470000184
• UDI-Public: 00817470000184
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/30/2020

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: NEEDLE AND SUTURE CAPTURE
• Device Catalogue Number: 22-4035
• Device Lot Number: K5001Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2020
• Initial Date Received by Manufacturer: 05/06/2020
• Supplement Date Received by Manufacturer: 07/13/2020; 07/13/2020
• Initial Report FDA Received Date: 06/05/2020
• Supplement Report FDA Received Date: 07/16/2020; 07/30/2020
• 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: Other