MAUDE Adverse Event Report: TORNIER INC AEQUALIS FLEX REVIVE INSERTER-EXTRACTOR HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	ARS743000
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was an instrument breakage that occurred during set inspection.
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.
Event or Problem Description
It was reported that there was an instrument breakage that occurred during set inspection.
Additional Manufacturer Narrative
The reported event was confirmed, since the device was returned and matches the alleged failure mode the device inspection revealed the following: a visual inspection reveals inconsistent engagement and positioning of the foot in relation to the body of the instrument when the lever handle is not engaged.Based on investigation, the root cause was attributed to a wear related issue.The incident occurred due to the device being excessively used, which led to the internal spring losing its tension over time and eventually wearing out.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.

• Brand Name: AEQUALIS FLEX REVIVE INSERTER-EXTRACTOR HANDLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 19582168
• Report Number: 0001649390-2024-00274
• Device Sequence Number: 7392175
• Product Code: LXH
• UDI-Device Identifier: 00846832068883
• UDI-Public: 00846832068883
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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): 09/19/2024

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
• Device Catalogue Number: ARS743000
• Device Lot Number: EV0121362
• 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: 05/24/2024
• Supplement Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/19/2022
• 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