MAUDE Adverse Event Report: TORNIER S.A.S. FLEX SHOULDER SYSTEM REV INSERT D36 TH+6 STD ANGLE 12.5/B; PROSTHESIS SHOULDER JOINT POLYMER

Model Number	INSERT D36 TH+6 STD ANGLE 12.5/B
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) 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.

• Brand Name: FLEX SHOULDER SYSTEM REV INSERT D36 TH+6 STD ANGLE 12.5/B
• Common Device Name: PROSTHESIS SHOULDER JOINT POLYMER
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• MDR Report Key: 11986601
• Report Number: 3000931034-2021-00278
• Device Sequence Number: 14279098
• Product Code: KWS
• UDI-Device Identifier: 03700386940507
• UDI-Public: 03700386940507
• 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
• Report Date (Section B): 06/11/2021

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 Model Number: INSERT D36 TH+6 STD ANGLE 12.5/B
• Device Catalogue Number: DWF361B
• Device Lot Number: AC0065
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 06/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Weight: 65