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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. PLUG DRIVER; SCREWDRIVER

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ZIMMER BIOMET SPINE, INC. PLUG DRIVER; SCREWDRIVER Back to Search Results
Catalog Number 2000-9061
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/05/2023
Event Type  malfunction  
Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
 
Event Description
It was reported that two polaris plug drivers fractured intra-op during final tightening.There was no patient impact.This is report one of two for this event.
 
Manufacturer Narrative
Device evaluation: the returned device matches the information in the complaint file and was examined.Visual inspection revealed the tip is deformed/twisted.Root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to wear through use over time or multiple sterilization cycles.Dhr review: per dhr review, the part was likely conforming when it left highridge control.Device usage: this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.Reference report 3012447612-2023-00347.
 
Event Description
It was reported that two polaris plug drivers fractured intra-op during final tightening.There was no patient impact.This is report one of two for this event.
 
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Brand Name
PLUG DRIVER
Type of Device
SCREWDRIVER
Manufacturer (Section D)
ZIMMER BIOMET SPINE, INC.
10225 westmoor dr.
westminster CO 80021
Manufacturer (Section G)
ZIMMER BIOMET SPINE, INC.
10225 westmoor dr.
westminster CO 80021
Manufacturer Contact
sabrina abla
10225 westmoor dr.
westminster, CO 80021
7206965158
MDR Report Key18059487
MDR Text Key327212162
Report Number3012447612-2023-00346
Device Sequence Number1
Product Code HXX
UDI-Device Identifier00880304893566
UDI-Public(01)00880304893566(10)ZB161201
Combination Product (y/n)N
Reporter Country CodeVM
PMA/PMN Number
EXEMPT
Exemption Number5645646
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 11/01/2023
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 Catalogue Number2000-9061
Device Lot NumberZB161201
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/02/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/19/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient SexPrefer Not To Disclose
Patient EthnicityNon Hispanic
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