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

Model Number DX801R

Device Problem Device Abrasion From Instrument Or Another Object (1387)

Patient Problem Missing Value Reason (3192)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

(b)(6).This has been in use for several weeks now.It resulted in black discoloration of the bone meal and even metal abrasion!.

Manufacturer Narrative

Investigation: the components have been examined visually and microscopically with a keyence vhx-5000 digital microscope and a panasonic dmc tz8 digital camera.It could be determined that there are several material abrasions on the components.Upper side and under side of the sleeve at the sideline.Inner side of the upper shell.On the top of the lower shell.Batch history review: the device quality and manufacturing history records have been checked for all available lot numbers and found to be according to our specification valid at the time of production.No similar incidents have been filed with products from this batch.Conclusion and root cause: based on the information available as well as a result of our investigation, the root cause of the failure is most probably user related.Rational: we assume that the device was incorrectly assembled by the user.The material abrasion on the components prove that the sleeve was inserted incorrectly.Therefor the upper side of the sleeve rubbed on the top of the lower shell.

• Brand Name: ERGOPLANT MICRO BONE-MILL 90X55MM
• Type of Device: MPLANTOLOGY: ERGOPLANT 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: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 7072584
• MDR Text Key: 93715766
• Report Number: 9610612-2017-00587
• Device Sequence Number: 1
• Product Code: LYS
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/12/2018

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/24/2017
• Initial Date Manufacturer Received: 11/08/2017
• Initial Date FDA Received: 11/30/2017
• Supplement Dates Manufacturer Received: 11/08/2017
• Supplement Dates FDA Received: 02/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other