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	09/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during the surgery the jaw of the firstpass jammed shut inside the shoulder while trying to pass tape through the tendon.The procedure was continued with a reusable firstpass handle, upon the first use of this passer the suture capture trap came loose and was left within the patient attached to the tape it was passing.An arthroscopic grasper was used to retrieve the loose material from the shoulder.A backup device was used to complete the surgery.No significant delay or patient injury reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Event or Problem Description
It was reported that during the surgery upon the first use of this passer the suture capture trap came loose and was left within the patient attached to the tape that it was passing.An arthroscopic grasper was used to retrieve the loose material from the shoulder.A backup device was used to complete the surgery.No significant delay or patient injury reported.
Additional Manufacturer Narrative
The reported device, intended for use in treatment, was not returned for evaluation.A relationship between the product and reported incident cannot be established as the product was not returned.Without the reported product a fully visual and functional evaluation cannot be performed and customer¿s complaint cannot be confirmed.An exact root cause cannot be determined without evaluation of the device; however, factors unrelated to the manufacture or design of the device that could have contributed to the reported event include: incorrect needle and needle capture loading and/or 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 during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.B5: event description updated.

• 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: 9195098
• Report Number: 3006524618-2019-00514
• Device Sequence Number: 2055264
• Product Code: NBH
• UDI-Device Identifier: 00817470000184
• UDI-Public: 00817470000184
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2019

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: 09/08/2021
• Device Catalogue Number: 22-4036
• Device Lot Number: 2020293
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/24/2019
• Supplement Date Received by Manufacturer: 11/21/2019
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 11/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1