MAUDE Adverse Event Report: TORNIER INC TORNIER PERFORM REVERSED FULL WEDGE BP 15 DG DIA 25MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number DWJ505

Device Problem Device Difficult to Setup or Prepare (1487)

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

Event Date 02/20/2024

Event Type  malfunction  

Event Description

During the primary surgery, there was difficulty threading a central screw into the 25mm full wedge baseplate.The procedure was completed using an alternative implant.The central screw size was 6.5x30mm.

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

During the primary surgery, there was difficulty threading a central screw into the 25mm full wedge baseplate.The procedure was completed using an alternative implant.The central screw size was 6.5x30mm.

Manufacturer Narrative

Correction: d4 lot #.The reported event was not confirmed, since the returned device is conforming to specifications and fully functional.The device inspection revealed the following: the visual inspection was performed on the received product and revealed few marks on the periphery of the baseplate more likely caused by the attempts to implant the device.Also, few water marks can be seen due to the decontamination process.The spacer seems to be in a position as intended.The functional inspection of the received product was performed using mwj123 screwdriver to insert the central screw into the returned baseplate which resulted in the screw seating into the correct position in the baseplate.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on investigation, the root cause was attributed to a user related issue.A potential cause of this issue could be a wrong manipulation of the parts assembled by the surgeon during the surgery.If any further information is provided, the complaint report will be updated.

• Brand Name: TORNIER PERFORM REVERSED FULL WEDGE BP 15 DG DIA 25MM
• Type of Device: 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: 18924276
• MDR Text Key: 337907947
• Report Number: 0001649390-2024-00116
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/30/2024

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: DWJ505
• Device Lot Number: CZ1223272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 03/18/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2023
• 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