MAUDE Adverse Event Report: ARTHROCARE CORP. MULTIFIX S-ULTRA 5.5MM KNOTLESS ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 72290001

Device Problem Material Separation (1562)

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

Event Date 08/02/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that during the surgery the device failed upon insertion; it broke off inside the patient's anatomy, but all the broken pieces were removed.A back-up device was available.No patient injuries or delay reported.

Manufacturer Narrative

The device, intended for use in treatment, was not returned for evaluation.A relationship between the product and reported incident cannot be established as the product was not returned.Without the reported product a visual and functional evaluation cannot be performed and customer¿s complaint cannot be confirmed.There was no manufacturing record review performed because lot number is not available as packaging was disposed of by user.An exact root cause cannot be determined without evaluation of the device; however, factors unrelated to the manufacture or design of the device that could have contributed to the reported event include: (1) improper suture loading.(2) over tensioning the suture.(3) misalignment of inserter handle.The instruction for use was reviewed and found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.The instruction for use states: use care to properly align the implant and inserter handle with the bone hole during pound-in.Avoid excessive probing.Do not bend or twist the inserter handle during and after insertion as damage to the implant or incomplete insertion may result.Do not deploy a bent or damaged implant.Do not over tension the sutures as breakage or tissue pull through may occur.Additionally, over tensioning the suture may result in incomplete insertion or implant pull out.Should the device or additional information be received, the complaint will be reopened and reevaluated.

• Brand Name: MULTIFIX S-ULTRA 5.5MM KNOTLESS ANCHOR
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 8952878
• MDR Text Key: 156316943
• Report Number: 3006524618-2019-00429
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00885556614204
• UDI-Public: 00885556614204
• Combination Product (y/n): N
• PMA/PMN Number: K153669
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 10/14/2019

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: 72290001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/08/2019
• Initial Date FDA Received: 08/31/2019
• Supplement Dates Manufacturer Received: 10/14/2019
• Supplement Dates FDA Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1