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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN VENTRODORSAL DISTAL LOCKING SCREW; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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ZIMMER BIOMET, INC. UNKNOWN VENTRODORSAL DISTAL LOCKING SCREW; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Impaired Healing (2378); Osteomyelitis (4533)
Event Type  Injury  
Manufacturer Narrative
(b)(4).Concomitant products: 47249536011 tibial nail - yellow 11 mm diameter 36 cm length use red proximal and red distal screws.Report source: foreign country: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the location of the device is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported patient was revised due to osteomyelitis in the distal tibia and wound healing disruption.Ventrodorsal distal locking screw was removed during the procedure.The infection was treated with wound debridement and insertion of vancomycin.Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.It was reported the patient underwent revision due to wound healing complications and infection.As wound healing complications can be attributed to underlying infection and part/lot is provided with conforming sterile certs, the complaint can be deemed not reportable.
 
Event Description
Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.It was reported the patient underwent revision due to wound healing complications and infection.As wound healing complications can be attributed to underlying infection and part/lot is provided with conforming sterile certs, the complaint can be deemed not reportable.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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
UNKNOWN VENTRODORSAL DISTAL LOCKING SCREW
Type of Device
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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 Key12506719
MDR Text Key272508943
Report Number0001822565-2021-02721
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Study
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 11/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/11/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
SEE H10 NARRATIVE
Patient Outcome(s) Hospitalization; Required Intervention;
Patient SexFemale
Patient Weight80 KG
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