MICRO NDLHLDR DIAM.COATED180MM STR FD258R

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-02-25 for MICRO NDLHLDR DIAM.COATED180MM STR FD258R manufactured by Aesculap Ag.

Event Text Entries

[139338531] (b)(4). Investigation: failure description: the needle holder is in a heavily used condition, several stains and points of corrosion can be found all over the surface. Also the working end is coated in black. A pictorial documentation was visually and microscopically carried out. Several signs of wear and tear, stains and corrosion can be found all over the surface. The working end including the coating in the jaw is worn. The working end of the provided needle holder is coated black and the screw has not the same color as the area around. In the screw slot, remains of a gold colored coating can be found. This is not according to the aesculap specifications; we assume this is from a third party maintenance. A stamp of the aesculap technical service cannot be found on the instrument. Batch history review: the device quality and manufacturing history records have been checked for the available lot number and found to be according to our specifications valid at the time of production. No similar incidents have been filed with products from this batch. Conclusion and root cause: based on the information available as well as a result of our investigation the root cause of the failure is most probably related to wear and tear. Associated medwatches: 9610612-2019-00113; 9610612-2019-00114; 9610612-2019-00116; 9610612-2019-00117.
Patient Sequence No: 1, Text Type: N, H10


[139338532] It was reported that intraoperatively the diamant coating comes off the instrument. It was reported that the needle holders (5) are losing the diamant coatings due to abrasion in the area of the branches (area where suture and needle is catches); this was noticed at the end of 2018. Five needle holders were effected one will be sent for evaluation. Per the surgeon, it seems to be a sign at the abrasion and not the whole coating coming off at the same time. The surgeon does not think that bigger particles have gotten into the wound. Micro particles in the form of abrasion are sure to be there already, since the signs of abrasion have only occurred in the area where the needle and thread are gripped. It was reported, the surgeon considers it is unlikely that the coating will came off during the sterilization process.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610612-2019-00115
MDR Report Key8366916
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-02-25
Date of Report2019-02-25
Date Facility Aware2019-02-12
Date Mfgr Received2019-02-01
Device Manufacturer Date2015-03-09
Date Added to Maude2019-02-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. NICOLE BROYLES
Manufacturer Street615 LAMBERT POINTE DRIVE
Manufacturer CityHAZELWOOD MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
Manufacturer Phone3145515988
Manufacturer G1AESCULAP AG
Manufacturer StreetPO BOX 40
Manufacturer CityTUTTLINGEN, 78501
Manufacturer CountryGM
Manufacturer Postal Code78501
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMICRO NDLHLDR DIAM.COATED180MM STR
Generic NameIMPLANTOLOGY: MICRO INSTRUMENT
Product CodeDZN
Date Received2019-02-25
Model NumberFD258R
Catalog NumberFD258R
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerAESCULAP AG
Manufacturer AddressPO BOX 40 TUTTLINGEN, 78501 GM 78501


Patients

Patient NumberTreatmentOutcomeDate
10 2019-02-25

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