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

Catalog Number OM-7500

Device Problem Device Slipped (1584)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the anchor did not engage when deployed during an arthroscopic stabilization procedure.When the surgeon attempted to remove the anchor, the metal tip stayed in the joint and had to be snapped into 3 pieces to remove.No patient injury or other complications were reported.

Manufacturer Narrative

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.Factors which could have contributed to the anchor breaking off the inserter includes: misalignment of the implant and inserter handle with the bone hole during insertion, bending of twisting the handle during and/or after insertion which could lead to implant damage, insufficient bone hole size, or inserting the implant beyond the laser line which can lead to difficulty in removing the inserter and lead to damage.There were no indications during manufacturing record review to suggest the device did not meet product specifications upon release into distribution.

• Brand Name: SPEEDLOCK
• 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: 6133076
• MDR Text Key: 61303751
• Report Number: 3006524618-2016-00335
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K090615
• 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: 03/02/2017

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 Catalogue Number: OM-7500
• Device Lot Number: 1148249
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2016
• Initial Date FDA Received: 11/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/02/2017
• 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