MAUDE Adverse Event Report: AESCULAP AG DUROGRIP MATHIEU NEEDLE HOLD.FINE 140MM; BASIC INSTRUMENTS

Model Number BM148R

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.This is a similar device report; the leading material is not sold to usa.

Event Description

It was reported that there was an issue with bm148r - durogrip mathieu needle hold.Fine 140mm.According to the complaint description, the insert from the jaw broke off into the patient's mouth.An additional medical intervention was necessary.Additional information was not provided.The adverse event/malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation: visual investigation: we received a (b)(6) in a decontaminated and used condition.The product shows that a piece of carbide inlay (tc) is missing in the jaw.Based on the surfaces of the soldered areas, the root cause of the loosing of the tungsten carbide inlay was most likely caused by an insufficient soldering during manufacturing in combination with detergents with a high phosphoric acid content during repeated reprocessing.These detergents with a high phosphorus content attacked the improper soldered joint and the inlay was detached by the forces acting to the device during application.Batch history review: the device quality and manufacturing history records (dhr) have been checked for all available lot numbers and the products found to be according to our specification valid at the time of production.The current failure rate is within the risk analysis and therefore acceptable; severity of failure according to risk analysis (2/5), probabability of occurrence (1/5).Explanation, rationale, conclusion and root cause: based on the information available as well as a result of our investigaiton, the root cause of the failure is most probably related to a manufacturing error.

• Brand Name: DUROGRIP MATHIEU NEEDLE HOLD.FINE 140MM
• Type of Device: BASIC INSTRUMENTS
• 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: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 16137082
• MDR Text Key: 307076437
• Report Number: 9610612-2023-00002
• Device Sequence Number: 1
• Product Code: HXK
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BM148R
• Device Catalogue Number: BM148R
• Device Lot Number: 4506518384
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2023
• Initial Date FDA Received: 01/11/2023
• Supplement Dates Manufacturer Received: 02/01/2023
• Supplement Dates FDA Received: 02/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2015
• 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
• Patient Outcome(s): Required Intervention