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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PHOENIX TROCHANTERIC FEMORAL NAIL ROD, FIXATION

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ZIMMER BIOMET, INC. PHOENIX TROCHANTERIC FEMORAL NAIL ROD, FIXATION Back to Search Results
Model Number N/A
Device Problem Device Operational Issue (2914)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 09/02/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). Medical devices: 3. 2mm x 560mm cocr thd tip, cat#: 14-441053 lot#: unk; antegrade femoral nail driver, cat#: 14-442017 lot#: unk; recon targeting arm, cat#: 14-442018 lot#: unk; recon drill 6mm x 489mm cat#: 14-442023 lot#: unk. The reported event could not be confirmed. Guide wire was discarded and thus not returned. Nail was returned, and the visual inspection of the returned product identified extensive damage to the holes of the nail. Due to the scratches and deformation to the proximal holes, no accurate dimensional analysis or functional testing can be performed. Device history record (dhr) was reviewed and no discrepancies were found. Review of the complaint history determined that no further action is required. A definitive root cause cannot be determined with the information provided. No corrective actions, preventive actions, or field actions resulted after investigation of this event. 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. Multiple mdr reports were filed for this event, please see associated report: 0001825034-2017-08539.
 
Event Description
It was reported that during a femoral nail procedure, the guide wire tip fractured off inside the patient's wound after hitting the nail, despite proper targeting and alignment during testing prior to device insertion into the patient. The nail was extracted and was reinserted, however the drill bit struck the nail again. The nail was extracted a second time and a different system was used to complete the procedure. The guide wire tip was unable to be removed from the patient's wound. Attempts have been made and additional information on the reported event is unavailable.
 
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Brand NamePHOENIX TROCHANTERIC FEMORAL NAIL
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 Key7372050
MDR Text Key103515694
Report Number0001825034-2018-02220
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
PK072161
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 03/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number14-443540
Device Lot Number579730
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/21/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/26/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/30/2012
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: 03/26/2018 Patient Sequence Number: 1
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