MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED 4.5MM LOCKING SCREW 26 MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	DWD026
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During the tightening of a dwd026 locking screw for the reverse ii glenoid system, the screw's head broke cleanly.Despite being sufficiently tightened with no additional effort required and the incident was reported.The surgery was completed without further complications.
Additional Manufacturer Narrative
Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.
Additional Manufacturer Narrative
The reported event was confirmed, since the device was returned for evaluation, and matches the alleged failure.The device inspection revealed the following: -the multidirectional screw is broken at the first threads of the screw head.-the hexagonal footprint is well deformed at the screw head.-a visual microscopic inspection showed that the device rupture corresponded to a fracture caused by a torsional overload, indicating that the device was subjected to high force during use.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.No indications of material, manufacturing or design related problems were found during the investigation.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by application of a high torsional force that contributed to the reported event.If any further information is provided, the complaint report will be updated.
Event or Problem Description
During the tightening of a (b)(6) locking screw for the reverse ii glenoid system, the screw's head broke cleanly.Despite being sufficiently tightened with no additional effort required and the incident was reported.The surgery was completed without further complications.

• Brand Name: AEQUALIS REVERSED 4.5MM LOCKING SCREW 26 MM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer (Section G): WRIGHT MEDICAL CORK (TORNIER ORTHOPEDICS IRELAND LTD); harnetts cross; macroom, co. cork NA ; EI NA
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18876170
• Report Number: 3000931034-2024-00100
• Device Sequence Number: 12734442
• Product Code: KWS
• UDI-Device Identifier: 03700386916649
• UDI-Public: 03700386916649
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K050316
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: DWD026
• Device Lot Number: AE6445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/15/2024
• Supplement Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 03/11/2024
• Supplement Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/27/2023
• 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
• Patient Sex: Unknown