MAUDE Adverse Event Report: TELEFLEX MEDICAL WECK DERMAHOOK 1/2 HOOK 10 PKG/BX 6 HKS/PKG; INSTRUMENT, SURGICAL, NON-POWE

Catalog Number	382805
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.If the sample becomes available at a later date, a follow-up report will be submitted with investigation results.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "two of the six weck derma hooks broke/snapped while being used to retract the patient's dura during a craniotomy surgery.These hooks were on traction, so when they broke, they startled the surgeon who was under the microscope during that time".2 units involved.Associated mdr: 3003898360-2025-00923.

• Brand Name: WECK DERMAHOOK 1/2 HOOK 10 PKG/BX 6 HKS/PKG
• Common Device Name: INSTRUMENT, SURGICAL, NON-POWE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: laura guadalupe gonzalez ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23732967
• Report Number: 3003898360-2025-00922
• Device Sequence Number: 9750783
• Product Code: HAO
• UDI-Device Identifier: 04026704599752
• UDI-Public: (01)04026704599752(11)240808(17)260205(10)73G2401288(21)
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/11/2025

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 Expiration Date: 02/05/2026
• Device Catalogue Number: 382805
• Device Lot Number: 73G2401288
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED.
• Patient Sex: Unknown