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

Catalog Number ARS742301

Device Problems Break (1069); Corroded (1131); Fracture (1260); Detachment of Device or Device Component (2907); Material Deformation (2976); Naturally Worn (2988)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/02/2023

Event Type  Injury  

Event 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.

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.

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 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
• Type of Device: 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
• MDR Text Key: 329549773
• Report Number: 0001649390-2023-00341
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181420
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention