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

Model Number DX801R

Device Problems Mechanical Problem (1384); Naturally Worn (2988)

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

Event Type  malfunction  

Event Description

It was reported to aesculap (b)(4) that an ergoplant micro bone-mill 90x55mm (part # dx801r) was used during a procedure performed on an unknown date.According to the complainant, a metal abrasion was observed in the collection container.The complaint device has been returned to the manufacturer for evaluation.No patient complications were reported as a result of the event.Although requested, additional information has not been made available.The malfunction is filed under (b)(4) reference (b)(4).

Manufacturer Narrative

Manufacturing site evaluation: the device was returned to the manufacturer for physical evaluation.A visual examination of the device was performed which revealed that visible damage / material abrasions were present on the surface of the sleeve.Additionally, the cutting disc showed visible damage as well as signs of corrosion.Furthermore, residue, noted as being silicate deposits, was detected on the surface of the post.Silicate coatings do not pose a risk to patients, nor do they pose a risk to the device as they do not impair the original device properties.An investigation of the device manufacturing records was conducted by the manufacturer for the lot # of the device in question.No non-conformances were reported.The devices were found to be according to specification at the time of production.Additionally, there were no similar complaints against the same lot with the same error pattern.All device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.The investigation into the cause of the reported problem was able to confirm the failure mode of metal abrasion.There was no indication that a device related error occurred.The damage observed in the area of the sleeve was indicative of the slide bashing not being mounted.The damage to the metal sleeve, as well as the cutting disc, cannot occur if the device is assembled completely and correctly (with slide bashing).Therefore, the root cause of the event was determined to be user error.

Manufacturer Narrative

This report has been reassessed based on new information and is no longer considered to be reportable.The failure mode risk analysis has been adjusted and severity is now 2(5), per results from applicable product safety case (psc).

• Brand Name: ERGOPLANT MICRO BONE-MILL 90X55MM
• Type of Device: BONE MILL
• 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: 13359949
• MDR Text Key: 286644064
• Report Number: 9610612-2022-00023
• Device Sequence Number: 1
• Product Code: LYS
• UDI-Device Identifier: 04038653451166
• UDI-Public: 4038653451166
• 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: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DX801R
• Device Catalogue Number: DX801R
• Device Lot Number: 52656131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2022
• Initial Date FDA Received: 01/26/2022
• Supplement Dates Manufacturer Received: 02/01/2022
• Supplement Dates FDA Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1