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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG MICRO NDLHLDR DIAM.COATED180MM STR IMPLANTOLOGY: MICRO INSTRUMENT

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AESCULAP AG MICRO NDLHLDR DIAM.COATED180MM STR IMPLANTOLOGY: MICRO INSTRUMENT Back to Search Results
Model Number FD258R
Device Problems Flaked (1246); Peeled/Delaminated (1454); Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
(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; 9610612-2019-00115; 9610612-2019-00117.
 
Event Description
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.
 
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Brand NameMICRO NDLHLDR DIAM.COATED180MM STR
Type of DeviceIMPLANTOLOGY: MICRO INSTRUMENT
Manufacturer (Section D)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
Manufacturer (Section G)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
Manufacturer Contact
nicole broyles
615 lambert pointe drive
hazelwood, MO 63042
3145515988
MDR Report Key8366922
MDR Text Key139339541
Report Number9610612-2019-00116
Device Sequence Number1
Product Code DZN
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/25/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFD258R
Device Catalogue NumberFD258R
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date02/12/2019
Event Location No Information
Date Manufacturer Received02/01/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/09/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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