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

Catalog Number	72205020
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a hip arthroscopy, the microraptor snapped, all parts were removed from patients hip.The procedure was completed with a s+n back up device.There was no surgical delay and no further complications were reported.Bone quality was normal.The back up device was used in the original bone hole.No void was left in the patient.The surgeon was ultimately satisfied with the surgical outcome.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H10: h3, h6: a device deficiency was not identified, and a visual and functional evaluation could not be performed 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.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.The root cause of the reported event could not be determined since the device was not returned for evaluation.Factors that can contribute to the reported failure 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 precautions and warnings related to the use of the device.No containment or corrective actions are recommended at this time.
Additional Manufacturer Narrative
H11: h2: corrected data on b5, e1, e4 and g2.
Event or Problem Description
It was reported that during a hip arthroscopy, after preparing the insertion site with a 2.7mm drill and cleaning the insertion site of all debris, the microraptor anchor snapped, all parts were removed from patients hip.The procedure was completed without delay using a s+n back up device in the originally drilled bone hole, leaving no void left in the patient.The surgeon was ultimately satisfied with the surgical outcome.

• 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: 17762324
• Report Number: 1219602-2023-01772
• Device Sequence Number: 7093820
• Product Code: MAI
• UDI-Device Identifier: 00885556722510
• UDI-Public: 00885556722510
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/09/2024

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: 04/19/2026
• Device Catalogue Number: 72205020
• Device Lot Number: 51124374
• 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: Not provided
• Supplement Date Received by Manufacturer: 01/23/2024; 05/09/2024
• Initial Report FDA Received Date: 09/17/2023
• Supplement Report FDA Received Date: 01/24/2024; 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2023
• 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
• Patient Age: 20 YR
• Patient Sex: Female
• Patient Weight: 68 KG