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

Model Number OM-7500

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 04/16/2018

Event Type  malfunction  

Manufacturer Narrative

Event Description

It was reported that the speedlock didn¿t tension during the procedure.The procedure was completed with a back-up device.No patient injury reported.

Manufacturer Narrative

The reported speedlock device, intended for use in treatment, was not returned for evaluation.Without the reported product a visual evaluation cannot be performed and customers complaint cannot be confirmed.From the information provided, the speedlock didn¿t tension.Factors unrelated to the manufacture or design of the device that could have contributed to the reported event include: (1) incorrect suture loading.Or (2) incorrect clinical suture being used.Improper suture loading or incorrect suture used can result in device failure or damage to the device.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

Manufacturer Narrative

There was a relationship found between the returned device and the reported incident.The visual inspection of the returned om-7500 speedlock shows a deployed device.The implant is missing.No manufacturing abnormalities could be visually identified.The snare wire loop was found hanging out of the reel.No sutures were returned with the device.The om-7500 device was received deployed and the anchor was missing and not available therefore a functional test could not be performed.The complaint was verified but the root cause could not be determined with confidence.Factors unrelated to the design and manufacture of the device which could have contributed to the complaint event are outlined in the precautionary states in the instruction for use ("ifu") provided with the device associated with set-up and use of the device.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
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 7509727
• MDR Text Key: 108267924
• Report Number: 3006524618-2018-00235
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00817470010558
• UDI-Public: (01)00817470010558(17)190930(10)1165225
• Combination Product (y/n): N
• PMA/PMN Number: K130196
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/30/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: OM-7500
• Device Catalogue Number: OM-7500
• Device Lot Number: 1165225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2018
• Initial Date Manufacturer Received: 04/20/2018
• Initial Date FDA Received: 05/13/2018
• Supplement Dates Manufacturer Received: 06/20/2018; 07/25/2018
• Supplement Dates FDA Received: 06/21/2018; 07/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1