MAUDE Adverse Event Report: TORNIER INC AEQUALIS FLEX REVIVE PROXIMAL BODY TRIAL 11DIA; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	ARS742502
Medical Device Problem Codes	Material Fragmentation (1261); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "stripped threads".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
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: a visual inspection of the returned exhibits signs of excessive usage.The device has significant severe scratches and discoloration marks at multiple sites.Deformation at the proximal end of the device.There is also damage along circumference of the device and as well as deformed thread could be observed.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.The failure was caused by the abnormal as well as extensive usage of the usage of the device.If any further information is provided, the complaint report will be updated.
Event or Problem Description
As reported: "stripped threads".

• Brand Name: AEQUALIS FLEX REVIVE PROXIMAL BODY TRIAL 11DIA
• 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: 19087492
• Report Number: 0001649390-2024-00160
• Device Sequence Number: 15239045
• Product Code: PHX
• UDI-Device Identifier: 00846832068821
• UDI-Public: 00846832068821
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K181420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2024

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
• Operator of Device: Other
• Device Catalogue Number: ARS742502
• Device Lot Number: CR1218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/15/2024
• Supplement Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown