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

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS VNGD PS BOX REAMER 62.5-67.5MM INSTRUMENT, MANUAL

  • 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 ORTHOPEDICS VNGD PS BOX REAMER 62.5-67.5MM INSTRUMENT, MANUAL Back to Search Results
Model Number N/A
Device Problems Break; Fracture; Tip
Event Date 11/25/2015
Event Type  Injury  
Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event. Review of device history records show that lot released with no recorded anomaly or deviation. Device availability - the device is reported to be available for evaluation; however, it has not been received by biomet orthopedics to date. In the event that the device is received and evaluated, a follow up report will be sent to the fda to provide results. There are warnings in the package insert that state that this type of event can occur: under care and handling of instruments, number 1 states, ¿surgical instruments and instrument cases are susceptible to damage for a variety of reasons including prolonged use, misuse, rough or improper handling. ¿.

 
Event Description

It was reported that patient underwent a knee arthroplasty on (b)(6) 2015. During the procedure, the tip of the reamer fractured. No pieces of the instrument were retained by patient. No further information has been provided.

 
Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.

 
Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch. Examination of returned device found no evidence of product non-conformance. Review of the device confirmed the reported condition. Product likely failed due to excessive force being applied during use.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameVNGD PS BOX REAMER 62.5-67.5MM
Type of DeviceINSTRUMENT, MANUAL
Manufacturer (Section D)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
megan haas
56 e. bell drive
warsaw , IN 46582
5743726700
MDR Report Key5306987
Report Number0001825034-2015-05081
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type FOREIGN,USER FACILITY
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/22/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/17/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device MODEL NumberN/A
Device Catalogue Number32-487231
Device LOT NumberZB140603
OTHER Device ID NumberN/A
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/16/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/22/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/11/2014
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

Patient TREATMENT DATA
Date Received: 12/17/2015 Patient Sequence Number: 1
-
-