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

Model Number	72205020
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during an arthroscopy procedure, after the microraptor anchor was implanted into the glenoid, the surgeon was unhappy with the fixation and pulled the anchor out and re-inserted.The surgeon was still unhappy with the fixation therefore pulled it out again and it broke into 2 pieces.The pieces were removed from the patient.The procedure was successfully completed with non-significant delay using an alternative anchor device.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.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 material specifications found that the storage requirements for the material are specified, and the material must comply with provided percentage composition specifications as measured by ash test.A clinical review states that the provided (undated/unlabeled) photo of the anchor was reviewed and appears to show the anchor broken in 2 pieces as reported.The patient impact beyond the reported is not anticipated.Factors that could have contributed to the reported event include an application of unintended inappropriate or excessive force to the device.No containment or corrective actions are recommended at this time.

• Brand Name: MICRORAPTOR KNOTLESS SA RGNSB
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, 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: 15457657
• Report Number: 1219602-2022-01399
• Device Sequence Number: 20553123
• Product Code: MAI
• UDI-Device Identifier: 00885556722510
• UDI-Public: 00885556722510
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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): 10/25/2023

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 Model Number: 72205020
• Device Catalogue Number: 72205020
• Device Lot Number: 51019974
• 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: 09/02/2022
• Supplement Date Received by Manufacturer: 10/20/2023
• Initial Report FDA Received Date: 09/20/2022
• Supplement Report FDA Received Date: 10/26/2023
• 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