MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MICRORAPTOR RGNSB SA UB II #1 STR BL CB; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	72204984
Medical Device Problem Code	Expulsion (2933)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).:.
Event or Problem Description
It was reported that during the surgery, after the microraptor anchor was deployed in the bone hole and it was being knotted it got released easily and fell off.No patient injuries or delay reported.Unknown how the surgery was completed.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection found an anchor with deformation.A review of the device records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A review of the material found that the storage requirements, material specifications, and material tests were appropriately documented.A complaint history review concluded this was a repeat issue.A review of risk management files found that the reported failure was documented appropriately.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.The complaint was confirmed.Factors that could have contributed to the reported event include an impact event inconsistent with normal use.No containment or corrective actions are recommended at this time.

• Brand Name: MICRORAPTOR RGNSB SA UB II #1 STR BL CB
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11828415
• Report Number: 1219602-2021-01136
• Device Sequence Number: 1059295
• Product Code: MAI
• UDI-Device Identifier: 00885556710319
• UDI-Public: 00885556710319
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K180361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2021

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: 07/22/2023
• Device Model Number: 72204984
• Device Catalogue Number: 72204984
• Device Lot Number: 2059014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2021
• Initial Date Received by Manufacturer: 04/26/2021
• Supplement Date Received by Manufacturer: 06/18/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 06/21/2021
• Patient Sequence Number: 1