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U.S. Department of Health and Human Services

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

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ZIMMER SURGICAL, INC. HIGH CAPACITY NARROW INTRAMEDULLARY TIP; LAVAGE HANDPIECE TIP Back to Search Results
Model Number N/A
Device Problems Delivered as Unsterile Product (1421); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/02/2023
Event Type  malfunction  
Event Description
It was reported by the distributorship that the products were found to be nonconforming.Our incoming inspection team member found hair like debris in the sterile package.The event occurred outside of surgery.There was no reported patient harm, or delay.Due diligence is complete, no further information is available at this time.
 
Manufacturer Narrative
This event is recorded with zimmer biomet under (b)(4).This medwatch is being filed as an initial report.E1 phone:(b)(6).G2: japan.Related reports: 0001526350-2023-00997.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.H3 other text : device not yet returned.
 
Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).Visual inspection confirmed there was debris inside 2 of the sealed packages.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.As the product was conforming, a root cause cannot be determined.The debris was confirmed; however, the product is conforming.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.Multiple mdr reports were filed for this event, please see associated report: 0001526350-2023-00997-1.
 
Event Description
There is no additional information available.
 
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Brand Name
HIGH CAPACITY NARROW INTRAMEDULLARY TIP
Type of Device
LAVAGE HANDPIECE TIP
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 Key17642740
MDR Text Key322185110
Report Number0001526350-2023-00998
Device Sequence Number1
Product Code FQH
UDI-Device Identifier00889024374966
UDI-Public(01)00889024374966(17)260123(10)65866471
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,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 12/15/2023
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 Number00515018200
Was Device Available for Evaluation? Device Returned to Manufacturer
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/02/2023
Initial Date FDA Received08/29/2023
Supplement Dates Manufacturer Received12/14/2023
Supplement Dates FDA Received12/15/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/30/2023
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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