MAUDE Adverse Event Report: ARTHROCARE CORP. ACCU-PASS DIRECT, CRESCENT XL; ACCESSORIES,ARTHROSCOPIC

Catalog Number	23-2005
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/28/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a hip arthroscopy procedure, when the surgeon was pushing the accu-pass direct suture passer crescent xl through the capsule the tip of the accupass broke due to a hit to the femoral neck.Backup device was available to complete the procedure.No significant delay and no patient 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
Internal complaint reference: (b)(4).H10 h3,h6: the device, used in treatment, was not returned for evaluation.A relationship, if any, between the subject device and the reported event could not be determined since the product was not returned for evaluation.The accupass tip is made of superelastic nitinol which is a biocompatible material however, since the tip is part of a surgical device it is not approved for implantation.The patient impact beyond possible corrosion, local irritation/discomfort, and/or migration of possibly retained non-implantable foreign body fragments cannot be determined.No further medical assessment can be rendered at this time.A review of the device history records for the device showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.The instructions for use (ifu) was reviewed and contains warnings and precautionary measures related to proper use of the device.A review of risk management files found that the reported failure was documented appropriately.Visual inspection and functional testing could not be performed since the device was not returned for evaluation.Thus, the complaint could not be verified, nor could a root cause be determined with confidence.Potential factors unrelated to the manufacture or design of the device that could have contributed to the reported event includes: (1) excessive force.No containment or corrective actions are recommended at this time.There are no indications to suggest the device did not meet product specifications upon release into distribution.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: ACCU-PASS DIRECT, CRESCENT XL
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10687038
• Report Number: 3006524618-2020-00888
• Device Sequence Number: 3027717
• Product Code: NBH
• UDI-Device Identifier: 00885556724569
• UDI-Public: 885556724569
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2020

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 Expiration Date: 06/25/2023
• Device Catalogue Number: 23-2005
• Device Lot Number: 2056895
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/28/2020
• Supplement Date Received by Manufacturer: 11/20/2020
• Initial Report FDA Received Date: 10/15/2020
• Supplement Report FDA Received Date: 12/13/2020
• 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: Required Intervention