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	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
The device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms 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.Two x-ray image dated one-month post primary and one seven months prior to revision shows four buttons used but does not indicate a root cause for the reported complaint.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.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of risk management files and instructions for use found that the reported failure was documented appropriately.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, infection and/or patient condition.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• 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
• MDR Report Key: 10480237
• Report Number: 1020279-2020-04358
• Device Sequence Number: 16801399
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 71934990
• Device Catalogue Number: 71934990
• Device Lot Number: 17EM11130
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/04/2020
• Supplement Date Received by Manufacturer: 06/19/2021
• Initial Report FDA Received Date: 09/01/2020
• Supplement Report FDA Received Date: 06/24/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 33 YR