MAUDE Adverse Event Report: AESCULAP AG ERGOPLANT MICRO BONE-MILL 90X55MM; DENTAL

Model Number DX801R

Device Problem Failure to Osseointegrate (1863)

Patient Problem Non-union Bone Fracture (2369)

Event Date 12/20/2022

Event Type  Injury  

Event Description

It was reported that there was an issue with dx801r - ergoplant micro bone-mill 90x55mm.According to the complaint description, the bone was harvested, pulverized, and used as the base of an implant.The metal powder was mixed with the crushed bone.After checking, there was discovered a place where the inside of the bone mill body was scraped.An additional medical intervention was necessary.Additional information was not provided.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

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

Manufacturer Narrative

Additional information/ correction: d4 - lot added.D9 - date returned to the manufacturer.H3 - device evaluation.H4 - production date added.H6 - codes updated.Investigation results: visual investigation: the product arrived in a decontaminated and used condition.In assembled condition, the product shows no damage.During the examination it was found that the cutting edge of the inner sleeve and the punch are damaged.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.There are no similar complaints against the same lot number with this error pattern.The review of risk assessment revealed that the overall risk level (severity 4(5) x 2(5) probability of occurrence) according to din en iso 14971 is still acceptable.Explanation and rationale: according to the customer, there was a metal abrasion in the collection container.This error pattern can only occur if a part, in this case the white plastic sleeve is not mounted and in this case is missing.This resulted in contact of the punch as well as the cutting sleeve with the grid plate (cutting plate) and thus metal abrasion in the container.If the bone mill is properly assembled (with the white sleeve), the punch rotates smoothly and does not touch the cutting disc, then there can be no malfunction.For the correct assembly, see the extract from the ifu in the appendix.Other possible scenarios are excluded from our side.We cannot accept the complaint for the above reasons.The product is no longer repairable and must not be used in this way.Conclusion and measures / preventive measures: based upon the investigation results the root cause is most probably user related.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.

• Brand Name: ERGOPLANT MICRO BONE-MILL 90X55MM
• 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: 16134054
• MDR Text Key: 307041370
• Report Number: 9610612-2023-00008
• Device Sequence Number: 1
• Product Code: LYS
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 04/20/2023

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: DX801R
• Device Catalogue Number: DX801R
• Device Lot Number: 52691215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2023
• Initial Date FDA Received: 01/10/2023
• Supplement Dates Manufacturer Received: 04/06/2023
• Supplement Dates FDA Received: 04/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2021
• 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