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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. SET SCREW DRIVER; SCREWDRIVER
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ZIMMER BIOMET SPINE INC. SET SCREW DRIVER; SCREWDRIVER Back to Search Results
Catalog Number 230H4001
Device Problems Fracture (1260); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/07/2021
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 a screwdriver did not release easily from a set screw intra-operatively.A second driver was used to complete the procedure without reported patient impacts.When the initial driver was inspected at the end of the procedure, the tip was found to have fractured off.
 
Event Description
It was reported that a screwdriver did not release easily from a set screw intra-operatively.A second driver was used to complete the procedure without reported patient impacts.When the initial driver was inspected at the end of the procedure, the tip was found to have fractured off.
 
Manufacturer Narrative
Corrections in d9 and h3.Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: visual inspection revealed the tip has fractured.Potential cause root cause was unable to be determined.This event could possibly be attributed to wear through use over time or multiple sterilization cycles.It could also be attributed to off-axis forces applied during use.Dhr review per dhr review, the part was likely conforming when it left zimmer biomet control.Device use this device is used for treatment.A follow-up report will be submitted if new information is received that changes the information provided in this report.
 
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Brand Name
SET SCREW DRIVER
Type of Device
SCREWDRIVER
Manufacturer (Section D)
ZIMMER BIOMET SPINE INC.
10225 westmoor dr.
westminster CO 80021
MDR Report Key12093404
MDR Text Key259196849
Report Number3012447612-2021-00203
Device Sequence Number1
Product Code HXX
UDI-Device Identifier00887868227431
UDI-Public(01)00887868227431(10)312244
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 08/12/2021
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 Number230H4001
Device Lot Number312244
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/19/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/07/2021
Initial Date FDA Received06/30/2021
Supplement Dates Manufacturer Received08/11/2021
Supplement Dates FDA Received08/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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