MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED MULTIDIR. SCREW D4.5 L 44 STERILE; SHOULDER JOINT METAL PROSTHESIS

Model Number	DWD144
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Locking screw from reverse 2 glenoid system broke off when tightening.The 4.5mm x 44mm multidirectional screw used with the reverse 2 baseplate was powered into the baseplate at a slow speed and once the locking threads started to engage the driver was removed, however the head of the screw came off with the driver.The locking threads on the screw did engage with the locking islet, however in a revision situation there is no head of the screw to aid the removal.
Additional Manufacturer Narrative
The device will not be returned as it remains implanted.If additional information becomes available, it will be provided in a supplemental report.Head of screw was disposed of during the case.
Additional Manufacturer Narrative
The reported event could be confirmed.The device was not returned but evidences were provided, based on the provided photo which matches the alleged failure and based on the reported data in the event description.The provided photo showed that the multidirectional screw is broken at the first threads of the screw head.The screw threading under the screw head was remained implanted into the patient.The event description reported that a motorized screwdriver was used ("[.] the 4.5mm x 44mm multidirectional screw used with the reverse 2 baseplate was powered into the baseplate at a slow speed (.)") which may have generated an excessive motorized torque on the screwhead threading, whereas the use of a manual screwdriver is recommended in the current surgical technique.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by inadequate training of the hcp.A review of the device history for the reported lot did not indicate any abnormalities.There was no similar complaint reported within the same lot.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
Locking screw from reverse 2 glenoid system broke off when tightening.The 4.5mm x 44mm multidirectional screw used with the reverse 2 baseplate was powered into the baseplate at a slow speed and once the locking threads started to engage the driver was removed, however the head of the screw came off with the driver.The locking threads on the screw did engage with the locking islet, however in a revision situation there is no head of the screw to aid the removal.

• Brand Name: AEQUALIS REVERSED MULTIDIR. SCREW D4.5 L 44 STERILE
• Common Device Name: SHOULDER JOINT METAL PROSTHESIS
• 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 ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13107528
• Report Number: 3000931034-2021-00363
• Device Sequence Number: 4696141
• Product Code: KWS
• UDI-Device Identifier: 03700386917127
• UDI-Public: 03700386917127
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 05/20/2022

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: Health Professional
• Device Expiration Date: 03/09/2025
• Device Model Number: DWD144
• Device Catalogue Number: DWD144
• Device Lot Number: 3925AV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/06/2021
• Supplement Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 12/29/2021
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2020
• 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