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

Model Number 72290001

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 08/06/2020

Event Type  Injury  

Event Description

It was reported that during a rotator cuff repair using multifix, after placing multiple healicoil regenesorb anchors, the doctor attempted to turn the knob and released inserter from anchor but this would not release.He finally tapped back on inserted handle and the anchor pulled out and pulled the knotless multifix anchor next it out as well.One anchor broke and just a part of it was extracted.After trying several times it did not work, so the procedure was completed using competitor device.No delays were reported.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The device used in treatment, was not returned for evaluation.A relationship, if any, between the subject device and the reported event could not be determined.A review of the device history records for the device showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A review of risk management files found that the reported failure was documented appropriately.A complaint history review concluded this was a repeat issue.A review of the instructions for use found: - pathologic bone conditions such as cystic changes or severe osteopenia, which would impair secure fixation of the implant.- pathological changes in the affected soft tissues, which would prevent secure fixation.- inadequate bone stock or comminuted bone surface(s), which would compromise secure fixation of the implant.- physical conditions that would eliminate or tend to eliminate adequate implant support or retard healing, i.E., blood supply limitation, previous infections, etc.- conditions such as senility, mental illness or alcoholism, which may impact the patient¿s ability or willingness to restrict activities or comply with physician instructions during the healing period.-do not implant the anchor in poor quality bone or where bone quantity is limited.Incomplete insertion or poor bone quality may result in implant pullout.Without the reported product a visual and functional evaluation cannot be performed and customer¿s complaint cannot be confirmed.Factors that could have contributed to the reported event include: (1) poor bone quality (2) misalignment of inserter handle.(3) bone hole size.(4) over tensioning the suture.(5) excessive probing.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• 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: 10469975
• MDR Text Key: 204868534
• Report Number: 3006524618-2020-00692
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72290001
• Device Catalogue Number: 72290001
• Device Lot Number: 2036942
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/06/2020
• Initial Date FDA Received: 08/30/2020
• Supplement Dates Manufacturer Received: 10/09/2020
• Supplement Dates FDA Received: 10/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR