MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS FLEX REVIVE PROXIMAL BODY TRIAL 17DIA; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	ARS742505
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the proximal body failed as the trial tray broke off into its taper during use by the physician.Despite this issue, the case outcome was unaffected, and the user expressed understanding after the procedure.
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that the proximal body failed as the trial tray broke off into its taper during use by the physician.Despite this issue, the case outcome was unaffected, and the user expressed understanding after the procedure.
Additional Manufacturer Narrative
Corrections: update to product details prompted to 3000931034 - te (mtbonnot) d1 product long description d2a common device name d2b product code d3 manufacturer entity d4 catalog # and lot/serial no.G1 manufacturing site.The reported event was not confirmed since the device was not returned for evaluation and no other evidence were provided.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.Indications of material manufacturing or design related problems were unable to be identified as the lot number was not communicated.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If device is returned or any further information is provided the investigation report will be reassessed.

• Brand Name: AEQUALIS FLEX REVIVE PROXIMAL BODY TRIAL 17DIA
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin MN 38330 ; FR 38330
• Manufacturer (Section G): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin MN 38330 ; FR 38330
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20819350
• Report Number: 0001649390-2024-00686
• Device Sequence Number: 12940801
• Product Code: KWS
• UDI-Device Identifier: 00846832068852
• UDI-Public: 00846832068852
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K181420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2025

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: ARS742505
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2024
• Supplement Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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