MAUDE Adverse Event Report: TORNIER INC TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX22MM STERILE; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	DWJ722
Medical Device Problem Codes	Positioning Failure (1158); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The screw was spinning and would not lock when inserted into the locking screw hole in the base plate.It was confirmed that the c-shaped ring in the locking screw hole had separated from the base plate and was spinning.When the inserted screw was pulled out, the c-shaped ring part was pulled out with the locking part of the screw.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
The screw was spinning and would not lock when inserted into the locking screw hole in the base plate.It was confirmed that the c-shaped ring in the locking screw hole had separated from the base plate and was spinning.When the inserted screw was pulled out, the c-shaped ring part was pulled out with the locking part of the screw.
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: visual inspection: the visual inspection was performed on returned device and revealed damaged threads of the screw and debris stuck in-between c-ring and screw space.Circular groves can be seen on the outer surface of the c-shape ring.Furthermore, the returned device underwent a functional inspection to verify the screw could be removed from c-share ring using a sample screwdriver.The inspection revealed that the screw is moved out of the ring and burr coming out to the space.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.Based on investigation, the root cause was attributed to a user related issue.The event was caused by improper and rough handling of the implant.Misalignment of the threads while insertion combined with the application of high torque lead to this type of damage to the threads of screw and the outer surface of c-shape ring damage, ultimately leading to the issue noted in the event.If more information is provided, the case will be reassessed.

• Brand Name: TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX22MM STERILE
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 20689208
• Report Number: 0001649390-2024-00650
• Device Sequence Number: 15599483
• Product Code: PHX
• UDI-Device Identifier: 00846832091232
• UDI-Public: (01)00846832091232(11)240312(17)290312(10)AG686
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161742
• 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): 02/13/2025

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 Catalogue Number: DWJ722
• Device Lot Number: AG6861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2024
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2024
• 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: Male