MAUDE Adverse Event Report: AESCULAP AG ROOT ELEVATOR STR.3.0MM #4S; DENTAL

Model Number DL362R

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/07/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with dl362r - root elevator str.3.0mm #4s.According to the complaint description, the instrument was broken during surgery, they need to modify the surgery to extract the piece of the instrument that was broken.An additional medical intervention was necessary.Additional information was not provided nor available the adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation: instrument was provided in used condition; visible traces of usage can be found all over the surface.The distal end is bent, the tip is fractured but the fragment was not provided.The analysis of the fracture pattern illustrated a forced fracture due to overload.No pores, inclusions or foreign bodies could be found on the point of rupture.Hardness test confirmed the pre-set values.Target: 530 +145 hv5; current: 563 hv5.Review of device history records: the device quality and manufacturing history records will be checked for the lot number 4512250369 from the quality coordinator of the production plant.If the review shows any conspicuities, the report will be updated, actions will be initiated.One similar incident by the same customer has been filed with products from this batch.The current failure rate is within the risk analysis and therefore acceptable; severity was 3(5) and probability 1(5), 10 ppm.Conclusion and preventive measures: a definitive root cause for the breakage cannot be determined.Due to the condition of the complained device (clearly visible traces of usage / bent and fractured working end) we assume the breakage was caused by an overload situation.Based upon the investigation results, a capa is not necessary.

• Brand Name: ROOT ELEVATOR STR.3.0MM #4S
• 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 gruen ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 16658029
• MDR Text Key: 312455244
• Report Number: 9610612-2023-00069
• Device Sequence Number: 1
• Product Code: EMJ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/08/2023

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: DL362R
• Device Catalogue Number: DL362R
• Device Lot Number: 4512250369
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2023
• Initial Date FDA Received: 03/31/2023
• Supplement Dates Manufacturer Received: 06/02/2023
• Supplement Dates FDA Received: 06/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2021
• 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