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

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.

• Brand Name: MICRO NDLHLDR DIAM.COATED180MM STR
• Type of Device: IMPLANTOLOGY: 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 Key: 8366922
• MDR Text Key: 139339541
• Report Number: 9610612-2019-00116
• Device Sequence Number: 1
• Product Code: DZN
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FD258R
• Device Catalogue Number: FD258R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/12/2019
• Date Manufacturer Received: 02/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1