MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL KNEE FUSION NAIL SK; ENDO-MODEL FUSION NAIL, MODULAR

Model Number	15-0028/08
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
"notified that during a fusion nail case, the resident was unable to advance the set screw.Another box was opened and used with no issue.The representative stated that while the cement was hardening in a fusion nail case, the morse taper was impacted.Then they went to engage the set screw but they were not able to advance it.In order to save time, a new implant was opened and used without issue.The delay was less than 4 minutes.Upon investigating the wasted implant later, the representative found the screw in the morse taper was assembled backwards.The part will be returned for the investigation." [customer].
Additional Manufacturer Narrative
The review of the device history record showed no deviations.This is the final supplemental report, the complaint is closed.
Event or Problem Description
"notified that during a fusion nail case, the resident was unable to advance the set screw.Another box was opened and used with no issue.The representative stated that while the cement was hardening in a fusion nail case, the morse taper was impacted.Then they went to engage the set screw but they were not able to advance it.In order to save time, a new implant was opened and used without issue.The delay was less than 4 minutes.Upon investigating the wasted implant later, the representative found the screw in the morse taper was assembled backwards.The part will be returned for the investigation." [customer].

• Brand Name: ENDO-MODEL KNEE FUSION NAIL SK
• Common Device Name: ENDO-MODEL FUSION NAIL, MODULAR
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• Manufacturer Contact: lisa effe ; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• MDR Report Key: 23424135
• Report Number: 3004371426-2025-00053
• Device Sequence Number: 15517287
• Product Code: KRO
• UDI-Device Identifier: 04026575175222
• UDI-Public: 04026575175222
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K151008
• 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): 10/16/2025

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: 15-0028/08
• Device Catalogue Number: 15-0028/08
• Device Lot Number: 2535004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2025
• 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: Unknown