MAUDE Adverse Event Report: TORNIER INC AEQUALIS REVERSED MULTIDIR. SCREW D4.5 L 20 STERILE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	DWD120
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2022
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that a rsa was performed.Base plate was placed on the scapular side, after insertion of three locking screws, a 20-mm length locking screw was inserted as a forth screw.When the surgeon checked that screw because it was not mating well with the base plate, the surgeon found that the locking threads were uneven.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation, and matches the alleged failure.The device inspection revealed the following: visually, the screw head threading was found well deformed.Bone/soft tissue residue was observed at the screw rod threading level.A functional inspection performed with a baseplate from the stock confirmed that the screw cannot tighten into the olive of the baseplate.The screw was not functional since the device was used as reported in the event description ("(.) a 20-mm length locking screw was inserted as a forth screw (.) it was not mating well with the baseplate"), it is not possible to determine if the threading deformation is due to a manufacturing issue or a user related misuse issue.The exact root cause of the complaint event cannot be determined.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 a rsa was performed.Base plate was placed on the scapular side, after insertion of three locking screws, a 20-mm length locking screw was inserted as a forth screw.When the surgeon checked that screw because it was not mating well with the base plate, the surgeon found that the locking threads were uneven.

• Brand Name: AEQUALIS REVERSED MULTIDIR. SCREW D4.5 L 20 STERILE
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15950557
• Report Number: 0001649390-2022-00115
• Device Sequence Number: 20667919
• Product Code: KWS
• UDI-Device Identifier: 03700386917080
• UDI-Public: 03700386917080
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K050316
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2023

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 Model Number: DWD120
• Device Catalogue Number: DWD120
• Device Lot Number: AD9645051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2022
• Supplement Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 12/09/2022
• Supplement Report FDA Received Date: 02/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/08/2022
• 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