MAUDE Adverse Event Report: TELEFLEX MEDICAL 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	03/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during use, the dermahook broke."the surgeon did a methodical sweep and an x-ray was taken.Radiation exposure was needed to ensure that all broken pieces were retrieved".No patient harm or injury.The patient status is reported as "fine".
Event or Problem Description
It was reported that during use, the dermahook broke."the surgeon did a methodical sweep and an x-ray was taken.Radiation exposure was needed to ensure that all broken pieces were retrieved".No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).From the attached pictures it was confirmed the defect reported by the customer "broken hook".However, it is necessary to receive the physical sample to perform a proper investigation, determine root cause and implement corrective actions.Per dhr the product dermahook 1/2 hook 10 pkg/bx 6 hks/pkg lot# 73g2400253 was manufactured on 07/10/2024 a total of (b)(4) pieces.Lot was released on 07/24/2024.Dhr investigation did not show issues related to complaint.Failure mode "broken hook" could be confirmed with a picture attached.However, it is necessary to receive the physical sample to perform a proper investigation, determinate the root cause and corrective actions.If the complaint samples become available at a later date, this complaint will be updated accordingly.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21731177
• Report Number: 3003898360-2025-00299
• Device Sequence Number: 18326618
• Product Code: HAO
• UDI-Device Identifier: 04026704599752
• UDI-Public: (01)04026704599752(11)240710(17)260107(10)73G2400253(21)
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2025

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: 01/07/2026
• Device Catalogue Number: 382805
• Device Lot Number: 73G2400253
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2025
• Supplement Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2024
• 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: Unknown