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

MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD PH3 TIB GROOVE CUTTER; PROSTHESIS, KNEE

  • 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
 

BIOMET UK LTD. OXFORD PH3 TIB GROOVE CUTTER; PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/27/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.
 
Event Description
It was reported that the handles on the instrument is cracked and can no longer be used in procedures.No further information is available at this time.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Visual inspection of the returned items identified there is a crack in the handle, therefore the reported event is confirmed.Device history record (dhr) was reviewed and no discrepancies were found.The likely condition of the device when it left zimmer biomet is conforming to specification.The reported event is likely to be cause by repeated cleaning and sterilisation cycles.Action resulted in a material change to the handle from radel to stainless steel.The stainless steel handle is more robust and able to withstand the cleaning/sterilisations cycles required for it to perform to its intended function.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
Event Description
It was reported that the handles on the instrument is cracked and can no longer be used in procedures.No further information is available at this time.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
OXFORD PH3 TIB GROOVE CUTTER
Type of Device
PROSTHESIS, KNEE
Manufacturer (Section D)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK  CF31 3XA
Manufacturer (Section G)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK   CF31 3XA
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key7048668
MDR Text Key93432747
Report Number3002806535-2017-01069
Device Sequence Number1
Product Code NRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PP010014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 11/22/2019
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 Physician
Device Model NumberN/A
Device Catalogue Number32-400691
Device Lot NumberZB100601
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/27/2017
Initial Date FDA Received11/21/2017
Supplement Dates Manufacturer Received04/06/2018
11/15/2019
Supplement Dates FDA Received04/06/2018
11/22/2019
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 Reuse
Removal/Correction NumberN/A
Patient Sequence Number1
-
-