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

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.

• Brand Name: PHOENIX TROCHANTERIC FEMORAL NAIL
• Type of Device: ROD, 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 Key: 7372050
• MDR Text Key: 103515694
• Report Number: 0001825034-2018-02220
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PK072161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 14-443540
• Device Lot Number: 579730
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2018
• Initial Date FDA Received: 03/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention