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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. HIGH CAPACITY INTRAMEDULLARY BRUSH TIP; LAVAGE, JET

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ZIMMER SURGICAL, INC. HIGH CAPACITY INTRAMEDULLARY BRUSH TIP; LAVAGE, JET Back to Search Results
Model Number N/A
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/10/2023
Event Type  malfunction  
Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4) g2 foreign: japan multiple mdr reports were filed for this event, please see associated report: 0001526350-2023-01612, 0001526350-2023-01614 evaluation and investigation is in process.Once the investigation is complete, a supplemental report will be filed.
 
Event Description
It was reported that during incoming inspection at the zb warehouse a foreign and hair like substance was found in the packaging.There was no patient involvement.Diligence is complete.No additional information is available.No adverse events were reported as a result of this malfunction.
 
Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001526350-2023-01612-1, 0001526350-2023-01614-1.This medwatch is being filed to relay additional information.Visual inspection confirmed there was hair-like debris inside the sealed package of the tips.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.The event is confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
Event Description
No additional event information available.
 
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Brand Name
HIGH CAPACITY INTRAMEDULLARY BRUSH TIP
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
jennifer rapsavage
56 e. bell drive
warsaw, IN 46582
5745260384
MDR Report Key18274070
MDR Text Key329831545
Report Number0001526350-2023-01613
Device Sequence Number1
Product Code FQH
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 03/26/2024
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 Number00515018300
Device Lot Number65925319
Was Device Available for Evaluation? Device Returned to Manufacturer
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/10/2023
Initial Date FDA Received12/06/2023
Supplement Dates Manufacturer Received03/25/2024
Supplement Dates FDA Received03/26/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/15/2023
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
Patient SexPrefer Not To Disclose
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