MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MICRORAPTOR KNOTLESS SA PEEK; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 72205021

Device Problem Unstable (1667)

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

Event Date 11/09/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, during a shoulder stabilization procedure, after a correct surgical deployment using a 2.2mm microraptor drill in a patient with reportedly not too hard bone, the microraptor knotless anchors withdrew from the bone hole after deployment.The surgeon tugged on the suture to ensure proper fixation but it wasn't stable.It was removed by tugging on sutures and withdrawing with graspers, there were no failed products left in the patient.A new bone hole was drilled after the first two microraptor knotless failed to provide stable fixation; however, once the new hole also failed, the surgeon proceeded with arthrex push lock.Surgery was resumed, after a non-significant delay, with a competitor device.No further complications were reported.

Manufacturer Narrative

H1 h6 the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification 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 was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.Per the provided customer feedback form ¿there was no failed products left in the patient.¿ the procedure was completed using a different device.No further risk to the patient is anticipated as a result of the additional bone hole.Since no further harm is anticipated no further clinical assessment is warranted at this time.There was no way to determine if the device contributed to the reported event.The complaint was not confirmed.Factors, which could have contributed to the complaint event, include misalignment with the drilled hole, excessive force during insertion, or inadequate bone quality.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: MICRORAPTOR KNOTLESS SA PEEK
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12879661
• MDR Text Key: 281313846
• Report Number: 1219602-2021-02590
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00885556722527
• UDI-Public: 00885556722527
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K181746
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72205021
• Device Catalogue Number: 72205021
• Device Lot Number: 50955693
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2021
• 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; Required Intervention