MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED MULTIDIR. SCREW D4.5 L 32 STERILE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	DWD132
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 1x 4.5mm 32mm superior multidirectional locking screw head broke off in-situ in the 25mm baseplate.The screw was inserted on hand and broke off before the threads were fully engaged.The screw head was left on driver after the driver was disengaged from the baseplate.
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed. should additional information become available, it will be provided on a supplemental report.Device remains implanted in patient.
Additional Manufacturer Narrative
The reported event could be confirmed.The device was not returned but picture was 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 head of the multidirectional screw was broken and was still hooked to the screwdriver.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.However, a probable root cause is due to an excessive force applied on the screw during the screwing.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that 1x 4.5mm 32mm superior multidirectional locking screw head broke off in-situ in the 25mm baseplate.The screw was inserted on hand and broke off before the threads were fully engaged.The screw head was left on driver after the driver was disengaged from the baseplate.
Additional Manufacturer Narrative
The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: a visual inspection was performed with a microscope.The screw was found broken at the first winding of the thread.Two spots of material accumulation were observed.Also, no signs of material deformation were observed: characteristic of a brittle fracture.Based on investigation, the root cause was attributed to applied force issue.As the screw was been inserted in the baseplate, experienced increased load application causing the head to detach.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.If more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that 1x 4.5mm 32mm superior multidirectional locking screw head broke off in-situ in the 25mm baseplate.The screw was inserted on hand and broke off before the threads were fully engaged.The screw head was left on driver after the driver was disengaged from the baseplate.

• Brand Name: AEQUALIS REVERSED MULTIDIR. SCREW D4.5 L 32 STERILE
• 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): 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: 14841479
• Report Number: 3000931034-2022-00248
• Device Sequence Number: 20032157
• Product Code: KWS
• UDI-Device Identifier: 03700386917103
• UDI-Public: 03700386917103
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K050316
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/19/2022

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: 05/12/2026
• Device Model Number: DWD132
• Device Catalogue Number: DWD132
• Device Lot Number: 4540AW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2022
• Supplement Date Received by Manufacturer: 07/19/2022; 10/17/2022
• Initial Report FDA Received Date: 06/28/2022
• Supplement Report FDA Received Date: 08/17/2022; 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2021
• 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