MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG LCU - HIP SYSTEM; 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	07/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The unviversal handle broke during surgery.[customer].
Event or Problem Description
The unviversal handle broke during surgery.[customer].
Additional Manufacturer Narrative
The review of this device history record is currently not possible due to temporarily unavailable archive data.The investigation is based on the documents provided.This investigation is considered sufficient to analyze the extent of the error.The recall r-2024-07 was initiated and completed.This is the final supplemental report.The complaint is closed.

• Brand Name: LCU - HIP SYSTEM
• 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: 20022092
• Report Number: 3004371426-2024-00057
• Device Sequence Number: 8600975
• Product Code: LXH
• UDI-Device Identifier: 04026575215539
• UDI-Public: 04026575215539
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2024

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 Model Number: 130-394/01
• Device Catalogue Number: 130-394/01
• Device Lot Number: C332137
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2024
• Supplement Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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