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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. PULS PLUS HIP KIT; DISPOSABLE BATTERY-POWERED SURGICAL/ORTHOPAEDIC LAVAGE SYSTEM

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ZIMMER SURGICAL, INC. PULS PLUS HIP KIT; DISPOSABLE BATTERY-POWERED SURGICAL/ORTHOPAEDIC LAVAGE SYSTEM Back to Search Results
Model Number N/A
Device Problem Expulsion (2933)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/02/2019
Event Type  malfunction  
Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).Upon receipt of additional information, the product return and the investigation is complete, a follow up/final report will be submitted.
 
Event Description
It was reported that during the surgery, this product became not to work after the surgeon sprayed about 300cc saline water with this product.After product was received for evaluation, it was discovered that there was liquid leaking from the 2 of 8 batteries.
 
Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).D4 udi: (b)(4).This medwatch is being filed to relay additional information.The device history record (dhr) for 00515048201 lot number 64453580, 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.On 05 february 2020, a returned product investigation was performed on the 00515048201.The physical evaluation revealed that the device had ruptured batteries, and the batteries had leaked inside of the battery pack.The results of the returned product investigation have confirmed the reported event.While the returned product investigation confirmed that the 00515048201 was not working due to ruputured batteries, it cannot be determined from the information provided what actually caused the batteries to rupture.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.Review of the information provided during the investigation determined there is no further actions needed at this time.This complaint will be tracked and trended for any adverse trends that may warrant further action.
 
Event Description
No additional event information available.
 
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Brand Name
PULS PLUS HIP KIT
Type of Device
DISPOSABLE BATTERY-POWERED SURGICAL/ORTHOPAEDIC LAVAGE SYSTEM
Manufacturer (Section D)
ZIMMER SURGICAL, INC.
200 west ohio avenue
dover OH 44622
MDR Report Key9178659
MDR Text Key161930592
Report Number0001526350-2019-00867
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 02/17/2020
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 Other
Device Expiration Date06/30/2022
Device Model NumberN/A
Device Catalogue Number00515048201
Device Lot Number64453580
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/05/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/02/2019
Initial Date FDA Received10/11/2019
Supplement Dates Manufacturer Received02/12/2020
Supplement Dates FDA Received02/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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