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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. CROSS CONNECTOR TORQUE WRENCH; WRENCH (RATCHETING HANDLES)
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ZIMMER BIOMET SPINE INC. CROSS CONNECTOR TORQUE WRENCH; WRENCH (RATCHETING HANDLES) Back to Search Results
Catalog Number 94624
Device Problem Fracture (1260)
Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Event Date 01/15/2020
Event Type  malfunction  
Manufacturer Narrative
Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.
 
Event Description
It was reported that during the procedure the tip of the torque wrench broke inside the locking nut when the doctor was trying to remove the cross connector.There was no further surgical information provided and no reported patient impacts.
 
Event Description
It was reported that during the procedure the tip of the torque wrench broke inside the locking nut when the doctor was trying to remove the cross connector.There was no further surgical information provided and no reported patient impacts.New information was received that reported the tip was retrieved and the cross connector was removed.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The event was confirmed with product received.Upon visual inspection the tip was deformed/twisted.The dhr was unable to be located.A corrective action has previously been initiated to address the issue.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental 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 Name
CROSS CONNECTOR TORQUE WRENCH
Type of Device
WRENCH (RATCHETING HANDLES)
Manufacturer (Section D)
ZIMMER BIOMET SPINE INC.
10225 westmoor dr.
westminster CO 80021
MDR Report Key9730161
MDR Text Key180131165
Report Number3012447612-2020-00069
Device Sequence Number1
Product Code HXC
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup,Followup
Report Date 10/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number94624
Device Lot Number123566
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/13/2020
Was the Report Sent to FDA? No
Date Manufacturer Received10/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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