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

Catalog Number	72205021
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during open medial epicondyle ligament reconstruction surgery, the body of the microraptor pk anchor was missing when it was about to be inserted in the bone tunnel.The failure was noticed after the device was loaded and just before deployment, the tip was seen to be in the deployed formation and the proximal section of the implant was missing.The missing section was search but it could not be found.The procedure was completed by changing the surgical technique, similar to a double row repair tightening the sutures to a knotted suture anchor.The tip was removed together with the implant holder were still attached.There was a delay less than 30 minutes and no further complications were reported.No further information nor details of the patient available.
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).
Additional Manufacturer Narrative
H10 h3: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.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 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 review of the microraptor knotless peek suture anchor found an assembly process summary that specifies the attachment of the 2.75mm anchor prior to the attachment of the distal anchor and the suture threader.A clinical review states that the proximal section of the implant remained in the patient, it is intended for implantation to allow for bone ingrowth, it is unknown if will migrate and there is potential risk for tissue inflammation and/or pain.Please refer to the instructions for use for precautions and warnings related to the use of the device.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
• Common Device Name: 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: 18348699
• Report Number: 1219602-2023-02478
• Device Sequence Number: 20168801
• Product Code: MBI
• UDI-Device Identifier: 00885556722527
• UDI-Public: 885556722527
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K181746
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/06/2026
• Device Catalogue Number: 72205021
• Device Lot Number: 51095724
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2023
• Supplement Date Received by Manufacturer: 01/11/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 01/15/2024
• Date Device Manufactured: 01/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown