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

Model Number	72205021
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Perforation (2001); Rupture (2208)
Date of Event	12/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a bankart under arthroscopy at the time of implantation the microraptor anchor was twisted without being forced or impacted, it was impossible to implant.The procedure was completed without surgical delay using a smith and nephew back up device in an additional drilled bone hole.No further complications were reported.
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.There was a relationship found between the device and the reported event.A visual inspection of the returned device found that it is not in its original packaging.The insertion device was returned without the suture threader or any suture material.The distal anchor was returned jammed back onto the 2.75mm anchor and stuck to the insertion device.The proximal end of the distal anchor is flared from being on top of the 2.75mm anchor.The interior of the distal anchor is damaged from force.There is debris on and in the returned anchors and insertion device.Based on the condition of the product material found during visual inspection, additional material testing is not required.A complaint history review found no similar reported events.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.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 assembly procedure found the operator should visually inspect the two implants to ensure that the proximal anchor is in the correct orientation and that no visible damage to either anchor has occurred.No further clinical assessment can be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.The complaint was confirmed, and the root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include excessive force on the device, excessive torque on the device, attempted correction of a damaged device, off-axis insertion, improper preparation of the insertion site, or an inadvertent impact event inconsistent with normal use.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.

• 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: 16235212
• Report Number: 1219602-2023-00101
• Device Sequence Number: 20415975
• Product Code: MBI
• UDI-Device Identifier: 00885556722527
• UDI-Public: 00885556722527
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2023

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: 09/23/2025
• Device Model Number: 72205021
• Device Catalogue Number: 72205021
• Device Lot Number: 51068327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2023
• Supplement Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 01/24/2023
• Supplement Report FDA Received Date: 04/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2022
• 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: Other
• Patient Sex: Unknown