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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. Z NAIL 10.5 X 95 LAG SCREW ROD, FIXATION

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ZIMMER BIOMET, INC. Z NAIL 10.5 X 95 LAG SCREW ROD, FIXATION Back to Search Results
Catalog Number 47-2485-095-10
Device Problems Fracture (1260); Malposition of Device (2616)
Patient Problem Non-union Bone Fracture (2369)
Event Date 12/03/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-07164. Udi: (b)(4). Z nail cpm 10mm x 38cm 125 l cat : 47-2493-381-10 lot : 2808701r; z nail 5. 0x57. 5 cort screw fa cat: 47-2484-057-50 lot: 62287327; z nail 5. 0x37. 5 cort screw fa cat: 47-2484-037-50 lot: 63641845; z nail 5. 0x35 cort screw fa cat: 47-2484-035-50 lot: 63711975; 3. 2mm threaded pin cat: 00-2490-450-32 lot: unk. Customer has indicated that the product will not be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Product not returned.
 
Event Description
It was reported that the patient underwent a revision procedure due to non union and fracture of the implant. During the procedure, it was noted that the lag screw was retroverted.
 
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Brand NameZ NAIL 10.5 X 95 LAG SCREW
Type of DeviceROD, 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 Key8206365
MDR Text Key131721766
Report Number0001822565-2018-07163
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K091566
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number47-2485-095-10
Device Lot Number2935501
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/18/2019
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

Patient Treatment Data
Date Received: 12/31/2018 Patient Sequence Number: 1
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