MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ROUND ENDOBUTTON 2-HOLE SS; SCREW, FIXATION, BONE

Model Number	71934990
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that on literature review "screw versus double endobutton fixation of the allograft for arthroscopic anatomic glenoid reconstruction in the treatment of recurrent anterior shoulder dislocation"; 1 patient had a re-dislocation after a glenoid bone repair procedure using a round endobutton device.The dislocation was resolved with a glenoid reconstruction using distal tibia allograft with screw fixation.No further information is available.
Additional Manufacturer Narrative
H10: h3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was no relationship found between the device and the reported event.A complaint history review found similar reported events.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.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.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.Per the complaint details, the patient experienced a re-dislocation post glenoid bone repair, where the endobutton device was used.The patient was treated with a revision (a glenoid reconstruction using distal tibia allograft with screw fixation).The images provided in the article (wong et al, 2021) have been interpreted within the text; therefore, no further analysis of the images is required.As of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.The patient impact beyond the reported is not anticipated, as it has been communicated that ¿the patient is doing well post-operatively¿ and no patient injury has been alleged.Therefore, no further clinical/medical assessment can be rendered.The complaint was not confirmed.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.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
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 specifications upon release for distribution.A complaint history review found 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 that the correct journal article was not provided for review.As of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.The patient impact beyond the reported cannot be determined.Therefore, no further clinical/medical assessment can be rendered.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: ROUND ENDOBUTTON 2-HOLE SS
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• 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: 15314546
• Report Number: 1219602-2022-01266
• Device Sequence Number: 17720688
• Product Code: HWC
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/14/2023

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: 17JM17900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2022
• Supplement Date Received by Manufacturer: 10/30/2022; 10/16/2022; 03/13/2023
• Initial Report FDA Received Date: 08/29/2022
• Supplement Report FDA Received Date: 10/06/2022; 10/17/2022; 03/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2017
• 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: Other
• Patient Age: 22 YR
• Patient Sex: Female
• Patient Weight: 63 KG