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

Model Number OM-7500

Device Problems Hole In Material (1293); Mechanics Altered (2984)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/24/2018

Event Type  malfunction  

Event Description

It was reported that reel popped and springs came out, suture could not be tensioned.Anchor was removed and an additional hole was made to complete the procedure.No significant delay or patient injury reported.

Manufacturer Narrative

The reported device was returned for evaluation and was intended for treatment.There was a relationship found between the returned device and the reported incident.Visual inspection of the device found that the returned speedlock device was received undeployed with te anchor detached.The spring came out and the wire snare loop is in good condition and its reeled into the wheel without clinical suture.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 the spring came out; however the root cause for the spring came out 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: incorrect suture loading or excessive tension applied.An exact root cause for the failed suture snaring cannot be determined with confidence after product evaluation.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 west william cannon drive; austin, TX 78735
• MDR Report Key: 7281329
• MDR Text Key: 100567206
• Report Number: 3006524618-2018-00087
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00817470010558
• UDI-Public: (01)00817470010558(17)190831(10)1164062
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130196
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: OM-7500
• Device Catalogue Number: OM-7500
• Device Lot Number: 1164062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2016
• 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