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U.S. Department of Health and Human Services

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

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ZIMMER SURGICAL, INC. PULS PLUS HIP KIT; LAVAGE, JET Back to Search Results
Catalog Number 00515048201
Device Problem Expulsion (2933)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/02/2019
Event Type  malfunction  
Manufacturer Narrative
This event has been recorded under zimmer biomet complaint number (b)(4).The customer has indicated that the device is in process of being returned for evaluation and the investigation is in process.Once the investigation is completed, a supplemental report will be filed accordingly.
 
Event Description
It was reported that during the surgery, water pressure of this product was lower than normal one.The surgeon tried to use this product for the surgery, but the hand-piece of this product abnormally generated heat.So, the surgeon stop using this product.The battery cable has been already cut off when we received this complaint product.The batteries showed signed of expulsion.No adverse events were reported as a result of this malfunction.
 
Event Description
No additional event information was received.
 
Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.The following sections were updated/corrected: d4: (b)(4).Reported issue: it was reported that during the surgery, water pressure of this product was lower than normal one.Dhr review: the device history record (dhr) for 00515048201 lot number 28576610, review noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with manufacturing.The dhr review found no issues with the device and all verifications, inspections, and tests were successfully completed.Technical review and physical evaluation: on 05 august 2019, it was reported from kobe university hospital that during the surgery, water pressure of this product was lower than normal one.On 05 august 2019, a returned product investigation was performed on the 00515048201.The physical evaluation revealed that the device was returned with the battery pack cable cut and a returned product investigation could not be completed.The results of the returned product investigation have not confirmed the reported event.Probable cause/root cause: the reported event could not be confirmed as the device was returned with the battery pack cut.Therefore, based on the information provided, a specific root cause of the reported event cannot be determined.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Conclusion: review of the information provided during the investigation determined there is no further actions needed at this time (ie/capa/scar/hhe/d).This complaint will be tracked and trended per complaint trending procedure for any adverse trends that may warrant further action.
 
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Brand Name
PULS PLUS HIP KIT
Type of Device
LAVAGE, JET
Manufacturer (Section D)
ZIMMER SURGICAL, INC.
200 west ohio avenue
dover OH 44622
MDR Report Key8920655
MDR Text Key155213485
Report Number0001526350-2019-00679
Device Sequence Number1
Product Code FQH
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 09/09/2019
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 Health Professional
Device Expiration Date08/31/2021
Device Catalogue Number00515048201
Device Lot Number28576610
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/31/2019
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/05/2019
Initial Date FDA Received08/22/2019
Supplement Dates Manufacturer Received09/09/2019
Supplement Dates FDA Received09/09/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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