MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG LINK EMBRACE SHOULDER SYSTEM LINE EXTENSION; DRILL TOWER, Ø 25, WEDGED

Model Number	645-081/62
Medical Device Problem Codes	Inadequate Instructions for Healthcare Professional (1319); Unclear Information (4052)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A field safety notice and capa was initiated as corrective action.
Event or Problem Description
It was noticed that the surgical technique for the embrace shoulder instruments - drill tower (article ref 645-081/62 &/63) have mixed-up article numbers in the overview of the instrument.
Additional Manufacturer Narrative
A field safety notice and capa was initiated as corrective action.Based on the investigation, the medical device problem code a "4052 - unclear information" was changed to "1319 - inadequate instructions for healthcare professionals." only the surgical technique is affected here; all labels and device markings are correct.This is the final supplemental report, the complaint is closed.
Event or Problem Description
It was noticed that the surgical technique for the embrace shoulder instruments - drill tower (article ref 645-081/62 &/63) have mixed-up article numbers in the overview of the instrument.

• Brand Name: LINK EMBRACE SHOULDER SYSTEM LINE EXTENSION
• Common Device Name: DRILL TOWER, Ø 25, WEDGED
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: lisa effe ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 24233045
• Report Number: 3004371426-2026-00009
• Device Sequence Number: 21128163
• Product Code: HTW
• UDI-Device Identifier: 04026575534715
• UDI-Public: 04026575534715
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2026

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: 645-081/62
• Device Catalogue Number: 645-081/62
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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