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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 POSITIONING GUIDE ROD INSTRUMENT, HIP

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ZIMMER BIOMET, INC. G7 POSITIONING GUIDE ROD INSTRUMENT, HIP Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/27/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Event occurred in (b)(6). 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.
 
Event Description
It was reported that during a hip arthroplasty the alignment guide broke during procedure. No adverse events have been reported as a result of the malfunction. Attempts have been made and no further information has been provided.
 
Manufacturer Narrative
Upon visual inspection the head had fractured at the threaded shaft. The tip of the rod is bent. G7 guide rod sample analyzed by sem showed that it fractured due to bending overload. Crack initiation site on the fracture surface could not be determined due to the fracture being smooth and relatively flat fracture, which did not reveal any artifacts. Quasi-cleavage mode of fracture exhibiting brittle cleavage planes and ductile overload dimples identified throughout the guide rod fracture. The dhr was reviewed and no discrepancies relevant to the reported event were found. A definitive root cause cannot be determined. 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 further event information available at the time of this report.
 
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Brand NameG7 POSITIONING GUIDE ROD
Type of DeviceINSTRUMENT, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8456252
MDR Text Key140288829
Report Number0001825034-2019-01461
Device Sequence Number1
Product Code LHX
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 09/19/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number110018822
Device Lot NumberZB150801
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/24/2019
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

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