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

MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. HIP KIT; LAVAGE, JET

  • 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 SURGICAL, INC. HIP KIT; LAVAGE, JET Back to Search Results
Model Number N/A
Device Problems Overheating of Device (1437); Battery Problem (2885)
Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)
Event Date 01/12/2017
Event Type  malfunction  
Manufacturer Narrative
The product will not be returning to the manufacturer for evaluation; however the investigation was not completed at the time of this report.A follow up medwatch will be submitted once the investigation is complete.
 
Event Description
It was initially reported that the battery pack from pulse lavage had been cut off and the retained battery pack overheated and was close to combustion.
 
Manufacturer Narrative
The complaint is being reported by zimmer biomet as (b)(4).This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Review of the device history record could not be performed as no lot number was reported for this complaint.Product examination could not be performed as no product was returned for this complaint.This complaint is non-verifiable.The reported event claimed that the battery wire of the unit was cut and later on the battery pack became hot and close to combustion.It is known that cutting the wire can create a short circuit within the battery pack.The pulsavac ifu states, ¿do not cut the battery pack cable.Cutting through the battery pack cable could lead to shock, excessive heat and/or sparks, and could result in fire and/or personal injury.¿ however, because no product was returned for this complaint, the root cause cannot be specifically determined with the provided information.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HIP KIT
Type of Device
LAVAGE, JET
Manufacturer (Section D)
ZIMMER SURGICAL, INC.
200 west ohio avenue
dover OH 44622
Manufacturer (Section G)
ZIMMER SURGICAL, INC.
200 west ohio avenue
dover OH 44622
Manufacturer Contact
christina arnt
56 e. bell drive
warsaw, IN 46582
5745273773
MDR Report Key6294440
MDR Text Key66560330
Report Number0001526350-2017-00060
Device Sequence Number1
Product Code FQH
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
PEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/26/2017
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 Health Professional
Device Model NumberN/A
Device Catalogue Number00515048200
Device Lot NumberUNKNOWN
Other Device ID Number00889024375185
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/12/2017
Initial Date FDA Received02/01/2017
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received06/26/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A
Patient Sequence Number1
-
-