MAUDE Adverse Event Report: AESCULAP AG ROOT ELEVATOR CVD.2.5MM #5C; DENTAL

Model Number DL371R

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/23/2021

Event Type  Injury  

Event Description

It was reported that there was an issue with dl371r- root elevator cvd.2.5mm #5c.According to the complaint description, the working end broke.During the removal of a displaced and impacted tooth (38), exposure and loosening of the tooth was performed.The broken off piece of the lifter initially got stuck in the alveolar compartment; however, it was removed with a forceps without any problems.An additional medical intervention was required.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: visual investigation: the working end of the instrument is broken.We have only the part of the instrument from which the front part is broken off.The broken piece is not included for investigation.The fracture has a homogenous surface.There are no signs of material defects such as inclusions or blowholes.In order to be able to make a more detailed examination, the broken off part should also be examined.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 2(5) x probability of occurrence 2(5)) according to din en iso 14971 is still acceptable.Explanation and rationale: we assume that the breakage is the result of excessive force being applied.Conclusion and measures /preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material, manufacturing or design-related failure.Based upon the investigations results a capa is not necessary.

• Brand Name: ROOT ELEVATOR CVD.2.5MM #5C
• Type of Device: DENTAL
• 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: 15050358
• MDR Text Key: 296140832
• Report Number: 9610612-2022-00180
• Device Sequence Number: 1
• Product Code: EMJ
• 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
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 07/19/2022

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: DL371R
• Device Catalogue Number: DL371R
• Device Lot Number: 4508309499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/22/2022
• Initial Date FDA Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2017
• 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