MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RND ENDBTN POST SST W-SZ3/4 SUTURE LOOP; WASHER, BOLT NUT

Model Number	71934993
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348); Joint Dislocation (2374); 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
D4 (lot number), e1, h6: updated.Report was inadvertently submitted under manufacturer number 1020279 but the correct manufacturer number is 1219602.
Additional Manufacturer Narrative
H10, 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 specifications upon release for distribution.A complaint history review found no similar reported events.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.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 clinical review states the provided report indicates resorption of the distal tibial allograft noted on an mri taken at two years post op.And two x-ray image dated one-month post primary and one seven months prior to revision shows four buttons used.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: RND ENDBTN POST SST W-SZ3/4 SUTURE LOOP
• Common Device Name: WASHER, BOLT NUT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 1450 brooks road; memphis, TN 38116 ; 0447940038246
• MDR Report Key: 10480186
• Report Number: 1020279-2020-04356
• Device Sequence Number: 2536387
• Product Code: HTN
• UDI-Device Identifier: 00885556424544
• UDI-Public: 00885556424544
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K183232
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/13/2023

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: 71934993
• Device Catalogue Number: 71934993
• Device Lot Number: 18AM04236
• 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; 02/10/2023
• Initial Report FDA Received Date: 09/01/2020
• Supplement Report FDA Received Date: 12/07/2021; 02/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown