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

Device Problems Break (1069); Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/15/2024

Event Type  malfunction  

Event 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.

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.

• Brand Name: AEQUALIS REVERSED 4.5MM LOCKING SCREW 26 MM
• Type of Device: 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
• MDR Text Key: 337341185
• Report Number: 3000931034-2024-00100
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 03700386916649
• UDI-Public: 03700386916649
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DWD026
• Device Lot Number: AE6445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2024
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: No
• 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