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 Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/14/2018
Type of Reportable Event	Serious Injury
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," 6 patients had a re-dislocation after a glenoid bone repair procedure using a double endobutton device.It is unknown how these events were treated.Patients outcome if known.No further information is available.
Additional Manufacturer Narrative
Internal complaint reference# (b)(4).Article cite: (b)(6).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, 2021,.
Additional Manufacturer Narrative
B5, d1 brand name, h6 health effect - impact code: updated.
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", 6 patients had a re-dislocation after a glenoid bone repair procedure using a double endobutton device.All of the patients were revised to a glenoid reconstruction using distal tibia allograft with screw fixation.All patients are doing well post-operatively since their revision surgery.No further information is available.
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", a patient had a re-dislocation after a glenoid bone repair procedure using a double endobutton device.The patient was revised to a glenoid reconstruction using distal tibia allograft with screw fixation.The patient is doing well post-operatively since the revision surgery.No further information is available.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H2: additional information in a1, a2, a3, a4, b5, d2, d4 (catalog no., lot no., udi no.), g4 (510k) & h4.Correction in d1 & h6 (health effect - impact code).
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 on (b)(6) 2018 using two (2) round endobutton devices.The dislocation was resolved with a revision surgery for glenoid reconstruction on (b)(6) 2019 using distal tibia allograft with screw fixation.No further information is available.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
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 pre-op and post-op images were provided for review but do not indicate a reason for the reported dislocation.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: 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
• 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: 13623419
• Report Number: 1219602-2022-00290
• Device Sequence Number: 20147780
• 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: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Literature,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/03/2023
• 2 Devices were Involved in the Event: 1 2

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: 17KM04705
• 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: 02/09/2022
• Supplement Date Received by Manufacturer: 05/04/2022; 08/05/2022; 09/08/2022; 10/17/2022; 02/28/2023
• Initial Report FDA Received Date: 02/28/2022
• Supplement Report FDA Received Date: 05/06/2022; 08/17/2022; 09/09/2022; 10/18/2022; 03/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2017
• 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: 32 YR
• Patient Sex: Female
• Patient Weight: 86 KG