MAUDE Adverse Event Report: AESCULAP AG ORTHOPILOT THA REAMER SHANK MPR HARRIS; HIP ENDOPROSTHETICS

Model Number FS960R

Device Problem Misconnection (1399)

Patient Problem Bone Fracture(s) (1870)

Event Date 06/24/2020

Event Type  Injury  

Manufacturer Narrative

Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.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.Conclusion and measures / preventive measures: in the light of the small amount of information received and due to the circumstance that we did not receive the complained devices for investigation, it is not possible to determine a root cause for the mentioned failure.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.

Event Description

It was reported that there was an issue with fs960r - orthopilot tha reamer shank mpr harris.According to the complaint description, the reamer instrument was damaged during the total hip replacement (thr) surgery.It was not fixed and thus migrated/wandered.This caused the acetabular cup portion of the acetabulum to be reamed more than planned.Although nh548t was implanted first, it was replaced with nt550t because it was not fixed.Finally, it was also not fixed, so all implants were removed.Pubis frature occurred due to the operation.An additional medical intervention was necessary.A multi-hole implant from another manufacturer was then used.Additional information was not available.Additional patient information is not available.The adverse event / malfunction is filed under aag reference (b)(4).Involved components fs974 - gloves protection f/fs959r/fs960r/fs961r - batch unknown.Nh550t - plasmacup dc size 50mm - 52521295.Nh548t - plasmacup dc size 48mm - 52543977.Nh522d - dc biolox delta insert 32mm 48/50 sym.- 52529914.

• Brand Name: ORTHOPILOT THA REAMER SHANK MPR HARRIS
• Type of Device: HIP ENDOPROSTHETICS
• 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: 11745902
• MDR Text Key: 261767534
• Report Number: 9610612-2021-00404
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FS960R
• Device Catalogue Number: FS960R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other; Required Intervention