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

Model Number 72290001

Device Problems Break (1069); Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)

Patient Problems Failure of Implant (1924); Muscular Rigidity (1968); Pain (1994)

Event Date 07/01/2020

Event Type  Injury  

Event Description

It was reported that, after a surgery was performed in which two multifix s ultra 5.5 mm had been implanted six months ago, it was found during the sonographic follow-up examination of the patient that the anchor has loosened.The patient complains of pain and restricted movement, so a sonographic examination was carried out and the loosening of the anchor, impingement at 90° was found.A revision surgery is planned for (b)(6) 2020.

Manufacturer Narrative

The device used in treatment, was not returned for evaluation.Per picture of the device, there was a relationship found between the reported incident and the returned device.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 complaint history review concluded this was a repeat issue.A review of risk management files found that the reported failure was documented appropriately.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.Clinical/medical evaluation was completed and concluded that the images provided are reported to indicate anchor loosening.With the images alone this is plausible but cannot be confirmed.Based on the information provided the root cause of the reported issue could not be determined.The revision was reported to be aug 6, 2020 but no new information has been provided to support the complaint.The patient impact beyond the reported of pain and restricted movement cannot determined.No further clinical/medical assessment is warranted at this time.Visual evaluation of x-ray image suggests anchor loosening.The complaint is confirmed.Factors that could have contributed to the reported event include: (1) bone quality (2) bone hole size.No containment or corrective actions are recommended at this time.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.

Manufacturer Narrative

H3, h6: one of the two reported devices was received for evaluation.A visual inspection revealed the device was not received in any original packaging.The anchor body, sleeve, and the screw were returned in a vial.There are no sutures with these pieces.The suture holes are intact.There is dried bio debris on each piece.A second vial holds a suture anchor, resembling a healicoil suture anchor.The anchor has broken threads/ribs and sutures that are run through it but cut short.Multiple pieces of the broken threads/ribs are included in the vial but does not appear to be all of it.Dried bio debris is on the anchor.A functional evaluation could not be performed due to the condition of the device.These findings are related to the reported event.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.The instructions for use were reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A clinical review states that three undated sonographic images have been provided for review which are reported to indicate anchor loosening.With the images alone this is plausible but cannot be confirmed.The root cause of the reported event could not be determined since findings cannot lead to a clear cause of the reported event.Factors that could have contributed to the reported event include: poor bone quality or an inadequate bone hole size.No containment or corrective actions are recommended at this time.Corrected data in h6: health effect - clinical code.Health effect - impact code.Medical device problem code.

• 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
• Manufacturer (Section G): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 10310977
• MDR Text Key: 199978181
• Report Number: 3006524618-2020-00527
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00885556614204
• UDI-Public: 00885556614204
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K153669
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/03/2024

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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/01/2020
• Initial Date FDA Received: 07/22/2020
• Supplement Dates Manufacturer Received: 09/21/2020; 04/30/2024
• Supplement Dates FDA Received: 09/29/2020; 05/03/2024
• 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
• Patient Outcome(s): Other