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 Code	Injury (2348)
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.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 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.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 (b)(4) but the correct manufacturer number is (b)(4).

• 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.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 10480075
• Report Number: 1020279-2020-04353
• Device Sequence Number: 14087340
• 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): 12/07/2021

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: 71934993
• Device Catalogue Number: 71934993
• Device Lot Number: 17BM14269
• 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: 08/16/2021; 08/16/2021
• Initial Report FDA Received Date: 09/01/2020
• Supplement Report FDA Received Date: 08/18/2021; 12/07/2021
• 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