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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.5 MM LOCKING SCREW 40 MM LENGTH; FIXATION, FASTENER
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ZIMMER BIOMET, INC. 3.5 MM LOCKING SCREW 40 MM LENGTH; FIXATION, FASTENER Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Skin Infection (4544)
Event Date 02/16/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4).Concomitant medical product: catalog #: 00235700706, distal medial tibial plate right 6 holes, lot # unknown; catalog #: 00235901235, 3.5 mm locking screw 12 mm length, lot # unknown; catalog #: 00235901835, 3.5 mm locking screw 18 mm length, lot # unknown; catalog #: 00235902835, 3.5 mm locking screw 28 mm length, lot # unknown; catalog #: 00235903235, 3.5 mm locking screw 32 mm length, lot # unknown; catalog #: 00235903635, 3.5 mm locking screw 36 mm length, lot # unknown; catalog #: 00235904035, 3.5 mm locking screw 40 mm length, lot # unknown; catalog #: 00235904035, 3.5 mm locking screw 40 mm length, lot # unknown; catalog #: 00235904035, 3.5 mm locking screw 40 mm length, lot # unknown; catalog #: 00235904235, 3.5 mm locking screw 42 mm length, lot # unknown; catalog #: 00483501801, 3.5 mm cortical screw self-tapping 18 mm length, lot # unknown; catalog #: 00483502601, 3.5 mm cortical screw self-tapping 26 mm length, lot # unknown; catalog #: 00483503801, 3.5 mm cortical screw self-tapping 38 mm length, lot # unknown; catalog #: 233240040, vpc screw 4.0x40mm, lot # unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-00567, 0001822565-2021-00568, 0001822565-2021-00570, 0001822565-2021-00571, 0001822565-2021-00572, 0001822565-2021-00573, 0001822565-2021-00574, 0001822565-2021-00575, 0001822565-2021-00576, 0001822565-2021-00578, 0001822565-2021-00579, 0001822565-2021-00580, 0001822565-2021-00581, 0001825034-2021-00610.
 
Event Description
It was reported patient had a distal medial tibia fracture.Fracture was reduced and fixated with a 6 hole tibia plate with an interfrag screw approximately 10 months ago.The doctor states the fracture is healed but the patient has reoccurring superficial skin infection over the plate and it needed to be removed.The plate was not fractured nor screws broke or retained with the exception of the max vpc screw.Attempts have been made and additional information on the reported event is unavailable at this time.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was found to traced to patient condition and non-device related factors.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.
 
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Brand Name
3.5 MM LOCKING SCREW 40 MM LENGTH
Type of Device
FIXATION, FASTENER
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key11406276
MDR Text Key234535469
Report Number0001822565-2021-00574
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
PMA/PMN Number
K042598
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 04/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number00235904035
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received04/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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