MAUDE Adverse Event Report: ARTHROCARE CORP. ACCU-PASS DIRECT CRESCENT XL; PASSER

Model Number 23-2005

Device Problem Bent (1059)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/13/2018

Event Type  malfunction  

Manufacturer Narrative

International zip code: (b)(6).

Event Description

It was reported that device was used to pass suture through labrum for hip repair.Device was bent and the shaft and instrument hook were stuck in the joint.Surgeon had to use graspers to remove the item and then the end of the hook snapped.Despite contact with reporter to confirm all pieces were removed, no response was received.No patient injury was reported.

Manufacturer Narrative

There was a relationship found between the device and the reported incident.Visual inspection of the returned device shows that the tip of the instrument is broken.The crescent on the tip was received separately.The accu pass direct crescent is a single used device and can be limited functional tested.The black hand lever was tested and performed as intended.The complaint was verified and the root cause could not be determined with certainty.Factors unrelated to the manufacture or design of the device that could have contributed to the reported event includes: improper handling, excessive drilling or improper alignment of the device.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: ACCU-PASS DIRECT CRESCENT XL
• Type of Device: PASSER
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer Contact: jim gonzales ; 7000 w. william cannon drive; austin, TX 78735
• MDR Report Key: 7325187
• MDR Text Key: 102111865
• Report Number: 3006524618-2018-00112
• Device Sequence Number: 1
• Product Code: HWQ
• UDI-Device Identifier: 00817470012200
• UDI-Public: (01)00817470012200(17)191231(10)1174558
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/25/2018

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: 12/31/2019
• Device Model Number: 23-2005
• Device Catalogue Number: 23-2005
• Device Lot Number: 1174558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2018
• Initial Date FDA Received: 03/08/2018
• Supplement Dates Manufacturer Received: 05/23/2018
• Supplement Dates FDA Received: 05/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1