MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG LINK EMBRACE SHOULDER SYSTEM; HANDLE, FOR COMPRESSOR AND PROXIMAL BODIES

Model Number	630-001/01
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The review of the device history record showed no deviations.The product complies with the specifications valid at the time of manufacture.Statement regarding the failure to meet the reporting deadline: the waldemar link gmbh & co.Kg was first notified about the incident on (b)(6) 2025.However, crucial information regarding the criticality of the event was available to waldemar link gmbh & co.Kg from october 29, 2025.
Event or Problem Description
During the rasping procedure of the humerus, a small piece was broken from the handle.[customer].
Event or Problem Description
During the rasping procedure of the humerus, a small piece was broken from the handle.[customer].
Additional Manufacturer Narrative
The review of the device history record showed no deviations.The product complies with the specifications valid at the time of manufacture.Statement regarding the failure to meet the reporting deadline: the waldemar link gmbh & co.Kg was first notified about the incident on (b)(6) 2025.However, crucial information regarding the criticality of the event was available to waldemar link gmbh & co.Kg from october 29, 2025.This is the final supplemental report, the complaint is closed.

• Brand Name: LINK EMBRACE SHOULDER SYSTEM
• Common Device Name: HANDLE, FOR COMPRESSOR AND PROXIMAL BODIES
• 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: 23581231
• Report Number: 3004371426-2025-00059
• Device Sequence Number: 13087566
• Product Code: PAO
• UDI-Device Identifier: 04026575278749
• UDI-Public: 04026575278749
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• PMA/510(K) Number: K200368
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2025

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: 630-001/01
• Device Catalogue Number: 630-001/01
• Device Lot Number: C441016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2025
• Supplement Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female