MAUDE Adverse Event Report: TORNIER INC AEQUALIS FLEX REVIVE PROXIMAL BODY TRIAL 9DIA; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number	ARS742501
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2024
Type of Reportable Event	Malfunction
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 during a training lab session at the st.Louis hub, the tab on the bottom of a size 9 revive proximal body bent during assembly.When an attempt was made to straighten the tab, it broke off completely.
Event or Problem Description
It was reported that during a training lab session at the st.Louis hub, the tab on the bottom of a size 9 revive proximal body bent during assembly.When an attempt was made to straighten the tab, it broke off completely.
Additional Manufacturer Narrative
The reported event was confirmed since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following the received device shows signs of extensive usage as evident by wear marks and scratches.The device exhibits clear breakage at the distal end, as it is returned with broken pieces.Overall damage indicates improper and rough handling.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 combination of user and wear related issue.The failure was caused by improper and rough handling.Since it has been long in use thus a normal weakened structural integrity due to repeated reprocessing cycles is considered possible.If any further information is provided the complaint report will be updated.

• Brand Name: AEQUALIS FLEX REVIVE PROXIMAL BODY TRIAL 9DIA
• Common Device Name: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• 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: 20397362
• Report Number: 0001649390-2024-00576
• Device Sequence Number: 3579093
• Product Code: HSD
• UDI-Device Identifier: 00846832068814
• UDI-Public: 00846832068814
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K181420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2025

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: Lay User/Patient
• Device Catalogue Number: ARS742501
• 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: 09/10/2024
• Supplement Date Received by Manufacturer: 12/18/2024
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 01/15/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown