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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. T7 DRIVER CANNULATED AO; SCREW, FIXATION

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ZIMMER BIOMET, INC. T7 DRIVER CANNULATED AO; SCREW, FIXATION Back to Search Results
Model Number N/A
Device Problem Bent (1059)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/02/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Mini ratchet handle ao, cat#:110017406 lot#: ni , hdls cmpn scr 2.5x22 ns, cat#:110018421 lot#: ni.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that during a scarf osteotomy to fix a hallux valgus, while seating the headless compression screw, the tip of the driver bent.No adverse events have been reported as a result of the malfunction.Attempts have been made and additional information on the reported event is unavailable.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product location is unknown.Reported event was confirmed by review of provided photographs.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Investigation results concluded that the reported event was due to plastic deformation as a result of the design of the device.These drivers have been designed to twist before fracture of the screw.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.Product location unknown.
 
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Brand Name
T7 DRIVER CANNULATED AO
Type of Device
SCREW, FIXATION
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 Key7504636
MDR Text Key107964118
Report Number0001825034-2018-03302
Device Sequence Number1
Product Code HWC
Combination Product (y/n)N
Reporter Country CodeNZ
PMA/PMN Number
PK142658
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/06/2018
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 Physician
Device Model NumberN/A
Device Catalogue Number110018531
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/02/2018
Initial Date FDA Received05/10/2018
Supplement Dates Manufacturer Received05/30/2018
Supplement Dates FDA Received06/06/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Age51 YR
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