• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG ACETABULAR REAMER HEAD STANDARD D52MM INSTR./MISCELL. FOR HIP ENDOPR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

AESCULAP AG ACETABULAR REAMER HEAD STANDARD D52MM INSTR./MISCELL. FOR HIP ENDOPR Back to Search Results
Model Number NF952R
Device Problems Loose or Intermittent Connection; Detachment of Device or device Component
Event Date 10/11/2018
Event Type  Injury  
Manufacturer Narrative

(b)(4). Received the complained device in decontaminated condition. The connection cross for the milling cutter has been loosened. The complained device has been sent to the manufacturer for investigation. The results of this investigation are still awaited. The device has been examined visually and microscopically with the digital microscope the welded joints of the connection cross for the milling cutter has been loosened. The cutting edges, especially on the largest circumference are visible damaged and have lost their sharp. Furthermore the device shows several traces which indicate intensive use. Extract from the ifu: inspection, maintenance and checks: *allow the product to cool down to room temperature. *after each complete cleaning, disinfecting and drying cycle, check that the product is dry, clean, operational and free of damage (e. G. Broken insulation or corroded, loose, bent, broken, cracked, worn, or fractured components). *dry the product if it is wet or damp. *repeat cleaning and disinfection of product that still show impurities or contamination. *check that the product functions correctly. *immediately put aside damaged or inoperative product and send them to aesculap technical services, see technical service. *assemble dismountable products, see assembling. *check for compatibility with associated products. The product does not require batch management; a review of the device quality and manufacturing history records is not possible. Based on the information available as well as a result of our investigation the root cause of the failure is most probably usage related. There is clearly signs of intensive use. The cutting edges, especially on the largest circumference are visible damaged and have lost their sharp. Therefore the usability is only possible with excessive force in pressure and lateral load. Finally this lead most probably to the failure of the welded seams. A capa is not necessary.

 
Event Description

It was reported by the healthcare professional to the company sales representative "during a hip surgery, the milling cutter is torn from its anchorage and the connection cross of the milling cutter has got into the soft tissues and torn the muscle there. It is not yet possible to estimate whether this has caused any nerve damage. From today the patient will be mobilized. In approx. 5 - 7 days it can be determined if and what really happened. Once additional information has been received regarding possible intervention and patient out come a follow up report will be submitted.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameACETABULAR REAMER HEAD STANDARD D52MM
Type of DeviceINSTR./MISCELL. FOR HIP ENDOPR
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 Key8052882
Report Number9610612-2018-00498
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 11/07/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/08/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberNF952R
Device Catalogue NumberNF952R
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/17/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date10/22/2018
Device Age5 yr
Event Location No Information
Date Manufacturer Received10/11/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/01/2013
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-