MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG GEMINI SL; TIBIAL COMPONENT

Model Number	318-482/02
Medical Device Problem Code	Accessory Incompatible (1004)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The review of the device history record showed no deviations.The final root cause is not comprehensible.
Event or Problem Description
Wrong screw in packaging - wrong screw was used.

• Brand Name: GEMINI SL
• Common Device Name: TIBIAL COMPONENT
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: annerike tizia hucklenbroch ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 15501117
• Report Number: 3004371426-2022-00037
• Device Sequence Number: 5256355
• Product Code: JWH
• UDI-Device Identifier: 04026575419913
• UDI-Public: 04026575419913
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K182872
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/31/2022

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 Model Number: 318-482/02
• Device Catalogue Number: 318-482/02
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2022
• Initial Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2022
• 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
• Patient Sex: Female