MAUDE Adverse Event Report: TORNIER INC UNKNOWN RETROVERSION ROD; 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	11/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided on a supplemental report.
Event or Problem Description
As reported: "version rod broke off in hole of revive inserter handle.".
Additional Manufacturer Narrative
Please note the corrections to d4 catalog number and d4 lot number.Due to this correction, the original reporting decision was incorrect and mfr report # should be disregarded.
Event or Problem Description
As reported: "version rod broke off in hole of revive inserter handle.".

• Brand Name: UNKNOWN RETROVERSION ROD
• 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: 20825270
• Report Number: 0001649390-2024-00688
• Device Sequence Number: 8717116
• Product Code: LXH
• UDI-Device Identifier: 00846832068883
• UDI-Public: 00846832068883
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 02/25/2025

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: Health Professional
• Device Catalogue Number: ARS743000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2024
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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