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	Positioning Failure (1158)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/27/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a shoulder arthroscopy stabilization, the depth of the "microraptor drill (1,6mm)" in bone when crossing the cartilage was not deep enough to anchor well the "microraptor regenesorb (sa, ub ii, #1 str bl cb)".Therefore, when knotting the anchor got released easily and had to be removed from the patient.It is unknown if a back-up device was available or if there was a delay in the surgical procedure.No additional complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.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 review of risk management files found that the reported failure was documented appropriately.A relationship, if any, between the subject device and the reported event could not be determined.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.

• 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: 10879953
• Report Number: 1219602-2020-01907
• Device Sequence Number: 2895698
• Product Code: MAI
• UDI-Device Identifier: 00885556710319
• UDI-Public: 00885556710319
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2021

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: 06/06/2022
• Device Model Number: 72204984
• Device Catalogue Number: 72204984
• Device Lot Number: 50853840
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/02/2020
• Supplement Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 11/20/2020
• Supplement Report FDA Received Date: 08/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention