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

Catalog Number OM-7500

Device Problems Break (1069); Detachment Of Device Component (1104); Device Slipped (1584)

Patient Problem No Information (3190)

Event Date 01/03/2017

Event Type  malfunction  

Manufacturer Narrative

Awaiting receipt of device.

Event Description

It was reported during an anchor placement for the repair of a labrium the anchor broke off the inserter in the joint space, the loose anchor was removed and replaced with a new anchor.

Manufacturer Narrative

The subject speedlock device was used for repair and returned for evaluation.There was a relationship found between the returned device and the reported incident.The returned speedlock implant was received undeployed with the anchor broke off.The snare line is reeled into the wheel with the clinical suture attached.The speedlock device is a single use device therefore a functional test cannot be performed and the failure cannot be replicated.The complaint was verified, but the root cause for the anchor broken off could not be determined with confidence.Factors unrelated to the manufacturing or design of the device that could have contributed to the reported event includes: use care properly align the implant, do not bend or twist the inserter handle during and after insertion.There were no indications that would suggest that 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: 6280985
• MDR Text Key: 66054266
• Report Number: 3006524618-2017-00028
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• PMA/PMN Number: K090615
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/05/2017

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: 1150325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/03/2017
• Initial Date FDA Received: 01/26/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/05/2017
• 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