MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MICRPTR RGNSRB STR ANCHR W/1ULTRBRDSTRBL; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	72204983
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	12/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that after an acetabular labrum repair/reconstruction where a microraptor was used, the patient had constant pain and a revision was performed.The condition was resolved and no further 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
H10: internal complaint reference: (b)(4).H3, h6: the reported device 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.¿ a complaint history review found no similar reported events.¿ 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 risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.Without the relevant clinical information, such as implantation/revision report, radiographs, fall/trauma history, rehab compliance report or the device the information provided is insufficient to determine the root cause of the reported pain that lend to a revision.Since it was reported the condition was resolved and no further complications were reported, no further clinical/medical assessment is warranted at this time.Should any additional relevant medical information be provided, this complaint will be re-assessed.There was no relationship found between the device and the reported event.The complaint was not confirmed.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.¿ corrected information in h6 (health effect - clinical code | health effect - impact code).

• Brand Name: MICRPTR RGNSRB STR ANCHR W/1ULTRBRDSTRBL
• 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: 11232010
• Report Number: 1219602-2021-00209
• Device Sequence Number: 3805877
• Product Code: MAI
• UDI-Device Identifier: 00885556710302
• UDI-Public: 00885556710302
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K180361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/14/2022
• Device Model Number: 72204983
• Device Catalogue Number: 72204983
• Device Lot Number: 50787525
• 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: 01/07/2021
• Supplement Date Received by Manufacturer: 09/27/2022
• Initial Report FDA Received Date: 01/26/2021
• Supplement Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2019
• 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