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

Model Number	72205021
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during a bankart's repair, the distal implant of a microraptor knotless split.The minitape was sliding within the distal implant before insertion into the hole, however, once the distal implant was tapped into the drilled hole to half its length, it would not slide effectively, therefore it was brought out and inserted into the hole only about less than a quarter of its length and then when pressure was applied to the minitape to bring the tissue in to form the soft-tissue bolster, the distal implant split and the whole anchor was wasted.Surgery was completed after a non-significant delay, using a back-up device instead.No further complications were reported.
Additional Manufacturer Narrative
H3, h6: a device deficiency was identified; however, the root cause of the reported event could not be determined since the device was not received for evaluation.An analysis of the customer provided images found the distal implant of the microraptor knotless broken within the tissue.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.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 that a material certificate of analysis is required.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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
Additional Manufacturer Narrative
The reported device was received for evaluation.A visual inspection of the returned device found that it is not in its original packaging.Both parts of the anchor were returned without the insertion device.Both the proximal and distal portions of the anchor are fractured and splayed out from their original configuration.There is biological debris on the returned items.A functional evaluation could not be performed due to the condition in which the device was received.Based on the condition of the product material found during visual inspection, additional material testing is not required.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.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 that a material certificate of analysis is required.An analysis of the customer provided images found the distal implant of the microraptor knotless broken within the tissue.The root cause has been 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.No containment or corrective actions are recommended at this time.
Additional Manufacturer Narrative
Health effect - impact code corrected.

• 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: 16855235
• Report Number: 1219602-2023-00622
• Device Sequence Number: 7658713
• Product Code: MBI
• UDI-Device Identifier: 00885556722527
• UDI-Public: 00885556722527
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup,Followup
• Report Date (Section B): 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/11/2025
• Device Model Number: 72205021
• Device Catalogue Number: 72205021
• Device Lot Number: 51056357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2023
• Supplement Date Received by Manufacturer: 07/12/2023; 01/25/2024; 01/25/2024
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 07/14/2023; 01/25/2024; 01/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2022
• 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
• Patient Sex: Unknown