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U.S. Department of Health and Human Services

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

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ZIMMER SURGICAL, INC. HIP KIT; LAVAGE, JET Back to Search Results
Model Number N/A
Device Problems Battery Problem (2885); Expulsion (2933)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/23/2017
Event Type  malfunction  
Manufacturer Narrative
This complaint is being reported by zimmer biomet as (b)(4).Customer has indicated that the product will not be returned [it has been discarded] to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that the battery of the pulsevac hip kit exploded at the end of the surgery after the battery was removed.There was no patient involvement and no adverse events have been reported as a result of the malfunction.
 
Manufacturer Narrative
This complaint is being reported by zimmer biomet as.(b)(4) investigation summary: 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.¿ the root cause cannot be specifically determined with the provided information because no product was returned for this complaint.
 
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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 Key6490832
MDR Text Key72801037
Report Number0001526350-2017-00191
Device Sequence Number1
Product Code FQH
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
PEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/07/2017
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 NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/27/2017
Initial Date FDA Received04/13/2017
Supplement Dates Manufacturer Received06/26/2017
Supplement Dates FDA Received07/07/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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
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