MAUDE Adverse Event Report: ARTHROCARE CORP. QFIX 1.8 MINI SUTURE ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 72290123

Device Problems Break (1069); Firing Problem (4011)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/09/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, during a fibular collateral ligament repair procedure using a qfix suture anchor, when the anchor was inserted into the fibula hole, the knot could not be slid and the suture broke into pieces.It is unknown if there was a back-up device available or if there was a surgical delay.No further complications were reported.Further details are not available.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).H3, h6: the reported device was received for evaluation.A visual evaluation showed the part was not received in any original packaging.The insertion tool was not returned.Two sutures were returned.One end of each suture is frayed with individual fibers at two different lengths which indicates use of a sharp instrument.The opposite end of the suture is factory cut.Based on the condition of the product material found during visual inspection, additional material testing is not required 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 similar reported events.The instructions for use was 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 review of the material specifications found the suture is tested for minimum and average suture strengths.A clinical review states an undated photo of the broken suture was provided for review and confirms the breakage.The patient's current condition is unknown and the patient impact beyond the reported events could not be determined based on the limited information provided.The root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include excessive force or use of sharp instruments near the device.No containment or corrective actions are recommended at this time.

• Brand Name: QFIX 1.8 MINI SUTURE 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: 14982156
• MDR Text Key: 295678959
• Report Number: 3006524618-2022-00314
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00885556662618
• UDI-Public: 00885556662618
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172165
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72290123
• Device Catalogue Number: 72290123
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2023
• 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): Required Intervention