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

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/14/2022

Event Type  malfunction  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 306069554
• Report Number: 0001649390-2022-00115
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 03700386917080
• UDI-Public: 03700386917080
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K050316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/08/2022
• 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