MAUDE Adverse Event Report: TORNIER S.A.S. FLEX SHOULDER SYSTEM REVERSED TRAY DIA. 40 TH 0 ECC 1.5; PROSTHESIS SHOULDER JOINT METAL

Model Number	DIA. 40 TH 0 ECC 1.5
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was necessary to remove the reverse shoulder prosthesis from the patient.An (b)(6) year old with mild-grade diabetes that presented infection with indication for removing the prosthesis.During the surgery, on (b)(6) 2021, the part of the humerus implant was removed without problems, followed by the removal of the glenoid implants.At this stage of the procedure, the following events were registered: contamination of the hexagonal screwdriver, dwd167 and replacement with another screwdriver of the same model suitable for fitting; with the spare screwdriver, the surgeon unsuccessfully attempted to remove the glenoid with normal force.Surgeon made another attempt, now with the greatest force, causing the tip of the screwdriver break inside the orifice of the glenosphere.The tip of the screwdriver remains inside the patient with the assembly of the glenosphere on the glenoid base plate.The doctor finished the procedure without removing the prosthesis.No, there was no delay.
Event or Problem Description
It was necessary to remove the reverse shoulder prosthesis from the patient.An 80-year-old with mild-grade diabetes that presented infection with indication for removing the prosthesis.During the surgery, on (b)(6) 2021, the part of the humerus implant was removed without problems, followed by the removal of the glenoid implants.At this stage of the procedure, the following events were registered: 1) contamination of the hexagonal screwdriver, dwd167 and replacement with another screwdriver of the same model suitable for fitting; 2) with the spare screwdriver, the surgeon unsuccessfully attempted to remove the glenoid with normal force.3) surgeon made another attempt, now with the greatest force, causing the tip of the screwdriver break inside the orifice of the glenosphere.The tip of the screwdriver remains inside the patient with the assembly of the glenosphere on the glenoid base plate.The doctor finished the procedure without removing the prosthesis.No, there was no delay.
Additional Manufacturer Narrative
Corrections to d6b - device was not explanted as of yet.H4 mfg date, h6 health impact code the reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available to determine the root cause of the complaint event.If device is returned or any further information is provided, the investigation report will be reassessed.H3 other text : device remains implanted.

• Brand Name: FLEX SHOULDER SYSTEM REVERSED TRAY DIA. 40 TH 0 ECC 1.5
• Common Device Name: PROSTHESIS SHOULDER JOINT METAL
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer (Section G): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer Contact: anna jusinski ; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330 ; 476613500
• MDR Report Key: 11979977
• Report Number: 3000931034-2021-00275
• Device Sequence Number: 16432294
• Product Code: KWS
• UDI-Device Identifier: 03700386941054
• UDI-Public: 03700386941054
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K122698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2021

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: Lay User/Patient
• Device Expiration Date: 09/10/2023
• Device Model Number: DIA. 40 TH 0 ECC 1.5
• Device Catalogue Number: DWF510
• Device Lot Number: 0570AU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/14/2021
• Supplement Date Received by Manufacturer: 11/30/2021
• Initial Report FDA Received Date: 06/10/2021
• Supplement Report FDA Received Date: 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2018
• 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: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 65 KG