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

Model Number 72205021

Device Problems Fracture (1260); Failure to Advance (2524)

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

Event Date 08/10/2022

Event Type  Injury  

Event Description

It was reported that, during use, the proximal part of the microraptor knotless anchor would not advance into the bone and snapped upon insertion.Surgery was resumed after a non-significant delay using a competitor device instead.No further complications were reported.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, during a lateral ligament repair, the proximal part of the microraptor knotless anchor would not advance into the bone and snapped upon insertion.All the broken pieces were removed with gillies forceps.Surgery was resumed after a non-significant delay using a swivelock from arthrex (competitor device) instead.No further complications were reported.

Manufacturer Narrative

H2: additional information ¿b5, h6: health effect - impact code¿.

Manufacturer Narrative

H3, 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 specifications upon release for distribution.A complaint history review found no similar reported events.A review of the material requirements table found that material certificate of analysis is required.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 was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.No relevant supporting clinical information has been provided to assist with a clinical investigation.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.The provided customer feedback form notes a breakage of the microraptor knotless anchor and a firstpass device.It was communicated via e-mail that ¿all were removed with gillies forceps.¿ the customer feedback form also notes that the patient was not injured a result from the reported events.Should any additional clinical information be provided, this complaint will be re-evaluated.There was no relationship found between the device and the reported event.The complaint was not confirmed.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.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: 15312459
• MDR Text Key: 298807284
• Report Number: 1219602-2022-01258
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• 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: 51018869
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2022
• 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