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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN BROACH FOR STEMMED TIBIALS SIZES 5-6 INSTRUMENT

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ZIMMER BIOMET, INC. NEXGEN BROACH FOR STEMMED TIBIALS SIZES 5-6 INSTRUMENT Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/14/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). 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. Report source: the event occurred in (b)(6).
 
Event Description
It was reported that during a procedure the surgeon noticed a sliver of metal (ms - metal sliver) lodged on his glove. The instrument was isolated from use, and replacements from a new sterilized set were opened for use for the remainder of the surgery. Upon inspection of the broach, the surgeon identified that the instrument had fractured. Attempts have been made, and no further information is available.
 
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Brand NameNEXGEN BROACH FOR STEMMED TIBIALS SIZES 5-6
Type of DeviceINSTRUMENT
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key8760430
MDR Text Key150165338
Report Number0001822565-2019-02785
Device Sequence Number1
Product Code LHX
Combination Product (y/n)N
Reporter Country CodeSN
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/17/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number00597701305
Device Lot Number60603212
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/29/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/12/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/08/2006
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

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