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

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PATELLA REAMER BLADE WITH PILOT HOLE KNEE INSTRUMENT

  • 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
 

ZIMMER BIOMET, INC. PATELLA REAMER BLADE WITH PILOT HOLE KNEE INSTRUMENT Back to Search Results
Model Number N/A
Device Problem Device Stops Intermittently
Event Date 12/04/2017
Event Type  Malfunction  
Manufacturer Narrative

B)(4). The complaint device has been returned, but the device investigation has not yet been completed. Once the evaluation is completed, a supplemental medwatch 3500a will be submitted. 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 knee instrument stopped during the use. The new instrument was opened to complete the case.

 
Manufacturer Narrative

This follow-up report is being submitted to relay additional information. The following sections were updated: complaint sample was evaluated and the reported event was not confirmed. Evaluation of the returned patella reamer blade could not confirm any issue with it. The instrument does not bear any visual sign of damage. Dimensional analysis found that both the outer diameter and diameter of the central hole are conforming to print specifications. Device history record was reviewed and no discrepancies were found. The complaint was not confirmed, a definitive root cause cannot be determined with the information provided. 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

No further event information available at the time of this report.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePATELLA REAMER BLADE WITH PILOT HOLE
Type of DeviceKNEE INSTRUMENT
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw , IN 46582
5745273773
MDR Report Key7158100
Report Number0001822565-2018-00010
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/06/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/02/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number00597909551
Device LOT Number63845261
OTHER Device ID NumberN/A
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/15/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/30/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/20/2017
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

-
-