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

Catalog Number	ARS743000
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
Rep states "attachment on broach handle is loose".
Event or Problem Description
Rep states "attachment on broach handle is loose".
Additional Manufacturer Narrative
Please note the corrections to d4 lot #, d4 gtin and h6 health impact codes.The reported event could not be confirmed since the returned device is conforming to specifications and fully functional.The device inspection revealed the following the received device shows normal signs of usage as evident by presence of little wear marks scratches and water marks.Moreover functional test with sample proximal body was done with the returned handle and it was found that the inserter handle held onto the mating device as intended even with vigorous shaking.Hence reported event is not confirmed.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 could not be determined as returned device is functional and reported issue is not confirmed.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: 20873011
• Report Number: 0001649390-2024-00703
• Device Sequence Number: 15661240
• Product Code: LXH
• UDI-Device Identifier: 00846832068883
• UDI-Public: (01)00846832068883(10)EV0223209
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• 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): 03/04/2025

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: ARS743000
• Device Lot Number: EV0223209
• 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: 11/13/2024
• Supplement Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2023
• 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