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); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis results are not available at the time of this report.Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that a retaining pin in the extractor handle was found to be missing during set inspection, rendering the instrument unusable.There was no associated surgical case impacted by this issue.The instrument, part of a consignment kit, had been heavily used, though specific details regarding its time in service or the number of uses and sterilizations were unavailable.The kit had been inspected prior to being sent out, and the instrument has since been returned for further evaluation.
Event or Problem Description
It was reported that a retaining pin in the extractor handle was found to be missing during set inspection, rendering the instrument unusable.There was no associated surgical case impacted by this issue.The instrument, part of a consignment kit, had been heavily used, though specific details regarding its time in service or the number of uses and sterilizations were unavailable.The kit had been inspected prior to being sent out, and the instrument has since been returned for further evaluation.
Additional Manufacturer Narrative
Correction to h6(device code grid), d4(gtin) and h3.The reported event could be confirmed since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the visual inspection of the returned device reveals extensive usage.There are numerous wear and scratch marks throughout the surface of the device.The pin is missing near the extractor handle which supports the handle, hence affecting the overall functionality of the device.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 user related issue.The failure was caused by improper operation or handling of the device which further led to affecting the functionality of the device.The failure noted in this complaint was addressed with a capa.If any further information is provided the complaint report will be updated.

• 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: 20456352
• Report Number: 0001649390-2024-00595
• Device Sequence Number: 20781922
• Product Code: LXH
• UDI-Device Identifier: 00846832068883
• UDI-Public: (01)00846832068883(10)EV0120052
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 01/10/2025

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: Other
• Device Catalogue Number: ARS743000
• Device Lot Number: EV0120052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/16/2024
• Supplement Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2020
• 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