MAUDE Adverse Event Report: ARTHROCARE CORP. SPEEDLOCK HIP KNOTLESS FIXATION DEVICE; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	23-2001
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/19/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the suture was passed through anchor.Started winding sutures up and the internal wire snapped.Unable to load sutures any further.No patient injuries were reported.
Additional Manufacturer Narrative
There was a relationship found between the device and the reported incident.The snare line is reeled in to the wheels and the snare loop is found broken outside the wheel.No suture was returned/present.The customer complaint was verified but the potential root cause for the suture no longer reeling in is a broken snare loop can be due to over tensioning or use of a wrong type of suture which could cause the suture to get blocked and snapped.However, the exact root cause cannot be determined.There are no manufacturing abnormalities visually observed with the returned device.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.Device returned for evaluation.Device evaluated by the manufacturer.

• Brand Name: SPEEDLOCK HIP KNOTLESS FIXATION DEVICE
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 7171130
• Report Number: 3006524618-2018-00018
• Device Sequence Number: 11081921
• Product Code: MBI
• UDI-Device Identifier: 00817470003413
• UDI-Public: (01)00817470003413(17)200831(10)2006048
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K123240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: 23-2001
• Device Catalogue Number: 23-2001
• Device Lot Number: 2006048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2018
• Initial Date Received by Manufacturer: 12/19/2017
• Supplement Date Received by Manufacturer: 02/07/2018
• Initial Report FDA Received Date: 01/08/2018
• Supplement Report FDA Received Date: 02/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1