MAUDE Adverse Event Report: TORNIER INC LATITUDE TOTAL ELBOW ULNAR CAP LARGE; PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED

Model Number	DKY069
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a broken tail on the dky069.At the time of implantation not fully screwed into implant the implant.Patient sustained an injury resulting in broken cap.A revision surgery was performed.No further information is available.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by user accident.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that there was a broken tail on the dky069.At the time of implantation not fully screwed into implant the implant.Patient sustained an injury resulting in broken cap.A revision surgery was performed.No further information is available.
Additional Manufacturer Narrative
Please note the corrections made to the d4 lot number, h6 method, results, and conclusion code: the reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by user accident.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any additional information is provided, the investigation will be reassessed.

• Brand Name: LATITUDE TOTAL ELBOW ULNAR CAP LARGE
• Common Device Name: PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): WRIGHT MEDICAL CORK (TORNIER ORTHOPEDICS IRELAND LTD); harnetts cross; macroom, co. cork NA ; EI NA
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15480926
• Report Number: 0001649390-2022-00071
• Device Sequence Number: 17880581
• Product Code: JDB
• UDI-Device Identifier: 00846832010929
• UDI-Public: 00846832010929
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K07087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2022

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/24/2026
• Device Model Number: DKY069
• Device Catalogue Number: DKY069
• Device Lot Number: 2759AW012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/29/2022
• Supplement Date Received by Manufacturer: 09/27/2022
• Initial Report FDA Received Date: 09/24/2022
• Supplement Report FDA Received Date: 10/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Age: 74 YR
• Patient Sex: Female