MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RND ENDBTN POST SST W-SZ3/4 SUTURE LOOP; SCREW, FIXATION, BONE

Model Number	71934993
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374); Osteolysis (2377); Insufficient Information (4580)
Date of Event	08/04/2020
Type of Reportable Event	Malfunction
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
H3, h6: the device, used in treatment, was not returned for evaluation.The pictures provided were reviewed and could not confirm the stated failure mode.The clinical/medical investigation concluded that, 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 the same month as the primary shows 4 buttons and some radiolucency around the inferior one of this view.Without the 2-year mri, revision report 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 the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to procedural/user error, surgical complication or patient medical history.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
Additional Manufacturer Narrative
Report was inadvertently submitted under manufacturer number ¿1020279¿ but the correct manufacturer number is ¿1219602.¿.

• Brand Name: RND ENDBTN POST SST W-SZ3/4 SUTURE LOOP
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10613277
• Report Number: 1020279-2020-05011
• Device Sequence Number: 19153109
• Product Code: HWC
• 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
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/08/2021

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 Model Number: 71934993
• Device Catalogue Number: 71934993
• Device Lot Number: 18MM01602
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 08/18/2021; 09/08/2021
• Initial Report FDA Received Date: 10/01/2020
• Supplement Report FDA Received Date: 08/19/2021; 09/08/2021
• 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: 30 YR