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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL CUT GUIDE LEFT MEDIAL 5 DEGREES KNEE INSTRUMENT

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ZIMMER BIOMET, INC. TIBIAL CUT GUIDE LEFT MEDIAL 5 DEGREES KNEE INSTRUMENT Back to Search Results
Model Number N/A
Device Problems Fracture (1260); Mechanical Jam (2983)
Patient Problem No Information (3190)
Event Date 03/14/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Product has been received by zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported during surgery that the pin got stuck in drill hole and fractured. Subsequently, the procedure was completed with another device. No known adverse event was reported.
 
Manufacturer Narrative
Complaint sample was evaluated and the reported event was not confirmed. Visual examination exhibits signs of repeated use (nicked, gouged, burrs). Dhr was reviewed and no discrepancies were found. 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. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 00511.
 
Event Description
No further event information available at the time of this report.
 
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Brand NameTIBIAL CUT GUIDE LEFT MEDIAL 5 DEGREES
Type of DeviceKNEE INSTRUMENT
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8574624
MDR Text Key143877261
Report Number0001822565-2019-01839
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup
Report Date 02/12/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/02/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number42539905185
Device Lot Number63735849
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/17/2019
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

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