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
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.Resulted in the need for increased monitoring".(b)(4) units involved.Associated mdrs: 3003898360-2025-00922.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one unit of 382805 dermahook 1/2 hook 10 pkg/bx 6 hks/pkg for investigation.The returned samples were visually examined with and without magnification.Visual examination of the returned samples revealed that all six hooks were returned.No visible defects were observed for three of the hooks.One hook was returned covered in scratches and deformities, the band was not returned with the hook, and the suture thread was broken.The two remaining hooks were returned broken with broken bands and suture threads; additionally, both broken base halves were returned and only one hook half was returned.The base that the broken hook half belonged to could not be determined.The breaks on the two hook bases and hook half were observed to be shear clean breaks.The manufacturing team was consulted regarding the details of this complaint.The probable root cause of these breakages was determined to be supplier related.There was biological material observed on the devices.The ifu for this product, was reviewed as a part of this complaint investigation.The ifu states, "inspect each durahook and dermahook prior to use.Specifically, ensure the integrity of the elastic band.If the elastic band contains tears, splits or other damage, do not use.Do not overstretch the elastic band.Durahooks and dermahooks are sterile, single use and disposable.Do not resterilize." the reported complaint of "broken hook" was confirmed based upon the samples received.The customer returned one unit of 382805 dermahook 1/2 hook 10 pkg/bx 6 hks/pkg for investigation.The returned samples were visually examined with and without magnification.Visual examination of the returned samples revealed that all six hooks were returned.No visible defects were observed for three of the hooks.One hook was returned covered in scratches and deformities, the rubber band was not returned with the hook, and the suture thread was broken.The two remaining hooks were returned broken with broken bands and suture threads; additionally, both broken base halves were returned and only one hook half was returned.The base that the broken hook half belonged to could not be determined.The breaks on the two hook bases and hook half were observed to be shear clean breaks.The manufacturing team was consulted regarding the details of this complaint.The manufacturing team was consulted regarding the details of this complaint.The probable root cause of these breakages was determined to be supplier related.Nonconformance was opened by the manufacturing site to further evaluate this issue.A device history record review was performed on the device with no evidence to suggest a manufacturing related root cause.Teleflex will continue to monitor and trend on complaints 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.Resulted in the need for increased monitoring." 2 units involved.Associated mdrs: 3003898360-2025-00922 and 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: azhwan barazenda ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23732766
• Report Number: 3003898360-2025-00923
• Device Sequence Number: 9667724
• 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: Other
• Type of Report: Initial,Followup
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Supplement Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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.; NONE REPORTED.
• Patient Sex: Unknown