MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG FUSION NAIL

Model Number 15-0028/07

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Ambulation Difficulties (2544)

Event Date 10/17/2023

Event Type  Injury  

Event Description

Reported to linkbio on (b)(6) 2023 regarding a failure of a modular fusion nail, with dr.M.Originally implanted (b)(6) 2019 for revision surgery on (b)(6) 2023.It appeared that the implant being revised was implanted backwards.The screws are not recessed all the way, as they were inserted in the wrong side of the tibia component.Revision surgery was reported to be very successful.

• Brand Name: FUSION NAIL
• Type of Device: FUSION NAIL
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 18095061
• MDR Text Key: 327665401
• Report Number: 3006721341-2023-00023
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 04026575175215
• UDI-Public: 04026575175215
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/17/2023,11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2024
• Device Model Number: 15-0028/07
• Device Catalogue Number: 15-0028/07
• Device Lot Number: 1905130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/17/2023
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/17/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male