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

Model Number 71934990

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Joint Dislocation (2374)

Event Date 05/12/2019

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).Article: harper, a., sparavalo, s., ma, j., & wong, i.(2022).Fixation type does not affect the learning curve and short-term radiographic outcomes for arthroscopic anatomic glenoid reconstruction with distal tibia allograft.Arthroscopy, sports medicine, and rehabilitation, 4(2), (b)(4).

Event 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.

Manufacturer Narrative

Internal complaint reference: (b)(4).

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
• Type of Device: 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: 15316851
• MDR Text Key: 298857168
• Report Number: 1219602-2022-01275
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 00885556486191
• UDI-Public: 00885556486191
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K183232
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71934990
• Device Catalogue Number: 71934990
• Device Lot Number: 17AM14487
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Hospitalization
• Patient Age: 29 YR
• Patient Sex: Male
• Patient Weight: 98 KG