MAUDE Adverse Event Report: TORNIER INC TORNIER PERFORM REVERSED FULL WEDGE BP 15 DG DIA 25MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	DWJ505
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
During primary surgery it was reported by the customer that the central screw got stuck in the baseplate while fixing it in glenoid.The screw of appropriate diameter was used and could not be removed.Later it was replaced by a post.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the returned device was received in a damaged state, making proper functional inspection impossible.The device inspection revealed the following: a visual inspection revealed central screw and the baseplate in disassembled condition.The baseplate has few dent marks on the distal surface and contains a single spacer as intended.Furthermore, the device arrived in a disassembled state, a functional inspection was conducted using a returned central screw to evaluate its removal from the baseplate.The screw only seated halfway in the central screw hole, likely due to damaged threads, making full assembly impossible.However, the removal from the halfway point was performed without difficulty, hence the event cannot be confirmed.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.However, intra-operative removal of a central screw from an implanted tornier perform reversed glenoid baseplate is not advised.If the central screw does not disengage from the baseplate, a new baseplate with the correct length central screw will need to be implanted.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 not following the operative technique and improper handling of the device leading to damaged threads and disassembling impairment.If more information is provided, the case will be reassessed.
Event or Problem Description
During primary surgery it was reported by the customer that the central screw got stuck in the baseplate while fixing it in glenoid.The screw of appropriate diameter was used and could not be removed.Later it was replaced by a post.

• Brand Name: TORNIER PERFORM REVERSED FULL WEDGE BP 15 DG DIA 25MM
• 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): WRIGHT MEDICAL CORK (TORNIER ORTHOPEDICS IRELAND LTD); harnetts cross; macroom, co. cork NA ; EI NA
• Manufacturer Contact: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21880851
• Report Number: 0001649390-2025-00266
• Device Sequence Number: 15611254
• Product Code: KWS
• UDI-Device Identifier: 00846832092109
• UDI-Public: (01)00846832092109(11)240917(17)290917(21)1560BB021
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K161742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2025

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: DWJ505
• Device Lot Number: 1560BB021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/17/2024
• 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: Unknown