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

Catalog Number 23-2001

Device Problems Failure To Adhere Or Bond (1031); Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/17/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the anchor fell off the end of shaft during insertion in a hip arthroscopy.The anchor was removed from the joint via the sutures that were threaded through it but was not able to be reattached onto the inserter.Three additional bone holes were created in order to complete the case using competitor anchors.No patient injury or other complications were reported.

Manufacturer Narrative

Visual evaluation of the returned speedlock hip device shows the implant was not fully deployed and the anchor broke off.The snare line and spring were reeled in with the clinical suture attached.Functional testing could be performed as the speedlock is a single use device.The customer¿s complaint has been visually verified, however, the root cause could not be determined.Potential factors unrelated to the manufacture or design of the device which may have contributed to the reported event includes: levering the device during insertion.It is possible that during or after insertion of the device, if the device is levered, the implant can break off prematurely.The instructions for use (ifu) outlines warnings and precautionary measures when using the device such as ¿use care to properly align the implant and inserter handle with the bone hole during insertion.Do not bend or twist the inserter handle during and after insertion, as damage to the implant or incomplete insertion may result.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: SPEEDLOCK HIP KNOTLESS FIXATION DEVICE
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• 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; austin, TX 78735 ; 5123585706
• MDR Report Key: 6082939
• MDR Text Key: 59801223
• Report Number: 3006524618-2016-00296
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K123240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 23-2001
• Device Lot Number: 1109735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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