MAUDE Adverse Event Report: TORNIER INC LATITUDE EV ULNAR STEM TRIAL 41MM SMALL LEFT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	9030280
Medical Device Problem Code	Residue After Decontamination (2325)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2024
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
As reported by the customer: "we have noticed an unknown, white, powder-like substance on the surface of certain latitude instruments.These substances seem to appear during the reprocessing of the instruments in a validated automatic washing process in cssd.These substances have been found on only some instruments, not all of them.".
Event or Problem Description
As reported by the customer: "we have noticed an unknown, white, powder-like substance on the surface of certain latitude instruments.These substances seem to appear during the reprocessing of the instruments in a validated automatic washing process in cssd.These substances have been found on only some instruments, not all of them.".
Additional Manufacturer Narrative
The reported event could be confirmed, from a photograph that was sent to us by the customer and matches the alleged failure mode.The device inspection revealed the following: a visual inspection shows that there are soap and/or water residue spots in the same pattern as the holes that would be in the instrument tray holding the instrument during the sterilization process.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 the above investigation and provided information, the root cause is attributed to insufficient cleaning and reprocessing at the user end.If any further information is provided, the complaint report will be updated.

• Brand Name: LATITUDE EV ULNAR STEM TRIAL 41MM SMALL LEFT
• 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: 18610600
• Report Number: 0001649390-2024-00028
• Device Sequence Number: 20724288
• Product Code: LXH
• UDI-Device Identifier: 00846832015238
• UDI-Public: 00846832015238
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2024

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
• Operator of Device: Other
• Device Catalogue Number: 9030280
• Device Lot Number: CC0117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/05/2024
• Supplement Date Received by Manufacturer: 04/16/2024
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2018
• 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