MAUDE Adverse Event Report: BIOMET TRAUMA PHOENIX RETROGRADE NAIL 13.5MM X 380MM; ROD, FIXATION, INTRAMEDULLARY

Model Number N/A

Device Problems Detachment Of Device Component (1104); Degraded (1153); Device Slipped (1584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/07/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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 : this report is number 2 of 2 mdrs filed for the same patient (reference 0001825034-2017-03883 ).

Event Description

It was reported that during a trauma femoral nailing procedure, upon attempted implantation, the nail continually disengaged and slipped off the jig.A second nail was attempted with the same results.Eventually, the threads were stripped and neither nail was implanted.A different nail system was utilized to complete the procedure after a twenty-five (25) minute delay to the procedure.No patient consequences were reported as a result of the malfunction.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.An examination of the returned devices was not possible.The returned product was scrapped in error, instead of being delivered to the postmarket surveillance lab.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action(s) is/are required.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.

• Brand Name: PHOENIX RETROGRADE NAIL 13.5MM X 380MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): BIOMET TRAUMA; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6639471
• MDR Text Key: 77515845
• Report Number: 0001825034-2017-03897
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK072161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 14-444438
• Device Lot Number: 446200
• Other Device ID Number: (01)00888480167204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2016
• 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 Weight: 95