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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CEPHALOMEDULLARY FLEXIBLE CAPTURED SET SCREW DRIVER STANDARD TRAUMA, INSTRUMENT

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ZIMMER BIOMET, INC. CEPHALOMEDULLARY FLEXIBLE CAPTURED SET SCREW DRIVER STANDARD TRAUMA, INSTRUMENT Back to Search Results
Catalog Number 00249003507
Device Problems Fracture (1260); Material Twisted/Bent (2981)
Patient Problem No Information (3190)
Event Date 12/14/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). (b)(6). Complaint sample was evaluated and the reported event was confirmed. The flexible portion was identified to have fractured. 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
It was reported flexible set screwdriver was bent irregularly. Once received, it was determined that the instrument was fractured.
 
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Brand NameCEPHALOMEDULLARY FLEXIBLE CAPTURED SET SCREW DRIVER STANDARD
Type of DeviceTRAUMA, INSTRUMENT
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key8617725
MDR Text Key145307733
Report Number0001822565-2019-01972
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K091566
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 05/16/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number00249003507
Device Lot Number63157076
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/25/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/29/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/03/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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