MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ROUND ENDOBUTTON 2-HOLE SS; WASHER, BOLT NUT

Model Number	71934990
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348); Osteolysis (2377)
Date of Event	08/04/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a glenoid bone loss surgery, a revision had to be performed.The surgeon noted excessive resorption on the distal tibial allograft associated with the use of the round endobutton, as compared to the resorption when using screw fixation.The resorption was noted in the 2 year follow-up mri and confirmed during the revision surgery.The patient's outcome is unknown.
Additional Manufacturer Narrative
Report was inadvertently submitted under manufacturer number (b)(4) but the correct manufacturer number is (b)(4).
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).H2: additional information in a2, d4 & h4 (exp.& mfg.Dates).H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined 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 specification upon release for distribution.A complaint history review found no 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.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.Although the provided report indicates resorption of the distal tibial allograft noted on an mri taken at two years post op, the image was not provided.An x-ray image dated 3 months post primary shows a satisfactory reduction in the dislocation.However, it cannot be used to identify the root cause of the reported event.Without the 2-year mri and the returned endobutton, the root cause of the reported event cannot be concluded.The patient impact beyond the reported clinical findings and the revision 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.

• Brand Name: ROUND ENDOBUTTON 2-HOLE SS
• Common Device Name: WASHER, BOLT NUT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• 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: 10480123
• Report Number: 1020279-2020-04355
• Device Sequence Number: 11397027
• Product Code: HTN
• UDI-Device Identifier: 00885556486191
• UDI-Public: 00885556486191
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K183232
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/28/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 71934990
• Device Catalogue Number: 71934990
• Device Lot Number: 17KM21601
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2020
• Supplement Date Received by Manufacturer: 08/04/2020; 02/27/2023
• Initial Report FDA Received Date: 09/01/2020
• Supplement Report FDA Received Date: 12/07/2021; 02/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2017
• 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: Hospitalization; Required Intervention
• Patient Age: 16 YR
• Patient Sex: Male