MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG LUBINUS SPII; UNIVERSAL HANDLE, WITH QUICK COUPLING, STAINLESS STEEL, STRAIGHT, PRODUCT

Model Number	130-394/01
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A field safety notice and capa was initiated as corrective action.Foreign event subsequent reporting due to (b)(4).
Event or Problem Description
The unviversal handle broke during a workshop.[customer].
Event or Problem Description
The universal handle broke during a workshop [customer].
Additional Manufacturer Narrative
A field safety notice and capa was initiated as corrective action.Foreign event subsequent reporting due to fsn r-2024-03.
Additional Manufacturer Narrative
The device history record was viewed and checked.The recall r-2024-07 was initiated and completed.This is the final supplemental report.The complaint is closed.
Event or Problem Description
The unviversal handle broke during a workshop.[customer].

• Brand Name: LUBINUS SPII
• Common Device Name: UNIVERSAL HANDLE, WITH QUICK COUPLING, STAINLESS STEEL, STRAIGHT, PRODUCT
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: andreas brandt ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 20144429
• Report Number: 3004371426-2024-00066
• Device Sequence Number: 15545784
• Product Code: LXH
• UDI-Device Identifier: 04026575215539
• UDI-Public: 04026575215539
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/10/2024

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: Health Professional
• Device Expiration Date: 08/30/2022
• Device Model Number: 130-394/01
• Device Catalogue Number: 130-394/01
• Device Lot Number: C204156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/10/2024
• Supplement Date Received by Manufacturer: 01/10/2024; 01/10/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 09/11/2024; 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown