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

Catalog Number	ARS742301
Medical Device Problem Codes	Break (1069); Corroded (1131); Fracture (1260); Detachment of Device or Device Component (2907); Material Deformation (2976); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During a recent surgery for a total reverse fracture case, a portion of the 9x20 trial spacer from the tornier flex revive humeral instruments tray fractured and became stuck inside the humeral canal.This incident caused a significant delay in the surgery.The surgical team had to remove a section of the humerus to access and remove the trapped trial stem, which was later reattached using cerclage.The incident resulted in a 3-hour surgical delay, but all debris was successfully removed using a bur instrument.
Additional 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.
Additional Manufacturer Narrative
The mdr is pending required code updates and complaint approval.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 scratches, gouges and heavy corrosion marks near the identification engravings.The device also has deformation at the proximal end and breakage around one of the grooves resulting from an improper handling and frequent usage.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 wear and user related issue.The failure was caused by improper handling and frequent usage.If any further information is provided, the complaint report will be updated.
Event or Problem Description
During a recent surgery for a total reverse fracture case, a portion of the 9x20 trial spacer from the tornier flex revive humeral instruments tray fractured and became stuck inside the humeral canal.This incident caused a significant delay in the surgery.The surgical team had to remove a section of the humerus to access and remove the trapped trial stem, which was later reattached using cerclage.The incident resulted in a 3-hour surgical delay, but all debris was successfully removed using a bur instrument.

• Brand Name: AEQUALIS FLEX REVIVE DISTAL STEM 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: 18251038
• Report Number: 0001649390-2023-00341
• Device Sequence Number: 15114386
• Product Code: HSD
• UDI-Device Identifier: 00846832068678
• UDI-Public: 00846832068678
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: ARS742301
• Device Lot Number: CR0118319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2023
• Supplement Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 02/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown