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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
Catalog Number 00515048200
Device Problems Battery Problem (2885); Expulsion (2933)
Patient Problem No Patient Involvement (2645)
Event Date 03/12/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Customer has indicated that product is in the process of being returned to zimmer biomet for investigation.Once the investigation is complete, a follow-up mdr will be submitted.
 
Event Description
It was reported that the battery pack had split and there was a black dust visible in the packaging.An alternate device was used in the event.No patient involvement.No adverse events were reported as a result of this malfunction.
 
Manufacturer Narrative
Dhr review: the device history record (dhr) for 00515048200, lot number z000011108, 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 (b)(6) 2019, it was reported from (b)(6) hospital that the battery pack had split and there was a black dust visible in the packaging.On 20 may 2019, a returned product investigation was performed on the 00515048200.The physical evaluation revealed that the device battery had ruptured within the sterile packaging.The results of the returned product investigation have confirmed the reported event.Probable cause/root cause: although the reported event was confirmed, it cannot be specifically determined from the information provided what caused the batteries to rupture.Therefore, the root cause could not 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.This complaint will be tracked and trended per complaint trending procedure for any adverse trends that may warrant further action.
 
Event Description
No additional event information available.
 
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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
MDR Report Key8545646
MDR Text Key142943698
Report Number0001526350-2019-00273
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 09/12/2019
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 Date02/28/2021
Device Catalogue Number00515048200
Device Lot NumberZ000011108
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/20/2019
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/15/2019
Initial Date FDA Received04/24/2019
Supplement Dates Manufacturer Received09/12/2019
Supplement Dates FDA Received09/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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