MAUDE Adverse Event Report: TORNIER INC TORNIER PERFORM REVERSED LATERALIZED BASEPLATE 3MM DIA 29MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	DWJ512
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Should additional information become available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that the surgeon used the baseplate inserter to attempt to remove a baseplate.The baseplate was well fixed and it deformed the baseplate inserter.Removal was due to patient infection.
Event or Problem Description
It was reported that the surgeon used the baseplate inserter to attempt to remove a baseplate.The baseplate was well fixed and it deformed the baseplate inserter.Removal was due to patient infection.
Additional Manufacturer Narrative
Corrections: d9 product available to stryker.H6 health impact codes.H6 method codes.The reported event was not confirmed, since the device was not returned for evaluation and no other evidence were provided.The device inspection was not possible as the product was not returned for investigation.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: TORNIER PERFORM REVERSED LATERALIZED BASEPLATE 3MM DIA 29MM
• 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: 20727467
• Report Number: 0001649390-2024-00663
• Device Sequence Number: 8395477
• Product Code: LXH
• UDI-Device Identifier: 00846832092079
• UDI-Public: 00846832092079
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 02/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: DWJ512
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2024
• Supplement Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Male