DURAHOOK 1/4 HOOK 10 PKG/BX 6 HKS/PKG 382800

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-12-17 for DURAHOOK 1/4 HOOK 10 PKG/BX 6 HKS/PKG 382800 manufactured by Teleflex Medical.

Event Text Entries

[130542630] Qn# (b)(4). The facility has communicated that the device is not available for evaluation. P/n 382800 is not being manufactured currently, however, another part number from the same family was use for the verification of failure mode reported in the current manufacturing process and was conducted as follows: 125 staplers were taken from the current production from p/n 382805 durahook 1/4 hook 10 pkg/bx 6 hks/pkg lot# 73l1800875 the staplers were visually inspected and issue reported "hook broken" was not observed in the current manufacturing process. A device history review could not be conducted since the lot number was not provided. Corrective actions cannot be established, the customer complaint cannot be confirmed, and the root cause cannot be determined since it is necessary to receive the physical sample to perform a proper investigation and to confirm the alleged defect. If the alleged defective samples become available at a later date, this complaint will be updated accordingly. Teleflex will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10


[130542631] It was reported that the hook was placed in the skull skin flap during procedure. Hooks were removed after the case. It was later noticed that one of the hooks was broken. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003898360-2018-01021
MDR Report Key8170763
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2018-12-17
Date of Report2018-12-05
Date of Event2018-11-30
Date Mfgr Received2018-12-05
Date Added to Maude2018-12-17
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactEFFIE JEFFERSON
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE 27560
Manufacturer CountryUS
Manufacturer Postal27560
Manufacturer Phone9194332672
Manufacturer G1TELEFLEX MEDICAL
Manufacturer StreetRANCHO EL DESCANSO
Manufacturer CityTECATE 21478
Manufacturer CountryMX
Manufacturer Postal Code21478
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDURAHOOK 1/4 HOOK 10 PKG/BX 6 HKS/PKG
Generic NameINSTRUMENT, SURGICAL, NON-POWE
Product CodeHAO
Date Received2018-12-17
Catalog Number382800
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressRESEARCH TRIANGLE PARK NC


Patients

Patient NumberTreatmentOutcomeDate
10 2018-12-17

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