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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 5.0 MM DIAMETER CORTICAL SCREW ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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ZIMMER BIOMET, INC. 5.0 MM DIAMETER CORTICAL SCREW ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number N/A
Device Problems Migration or Expulsion of Device (1395); Unstable (1667)
Patient Problem Joint Laxity (4526)
Event Date 08/22/2013
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: 47249532010 tibial nail - yellow 10 mm diameter 32 cm length use red proximal and red distal screws. Foreign: (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. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-02531.
 
Event Description
It was reported the patient experienced increasing feeling of instability under mobilization. Subsequently, the patient was revised on unknown date due to instability and dislocation of the nail. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand Name5.0 MM DIAMETER CORTICAL SCREW
Type of DeviceROD, 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 Key12728502
MDR Text Key279297386
Report Number0001822565-2021-03070
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K082770
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Study
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 01/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number47248403050
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/11/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2013
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 Treatment Data
Date Received: 11/01/2021 Patient Sequence Number: 1
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