MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PHOENIX 5MM SCREW AND ENDCAP; TRAUMA IMPLANT

Catalog Number 14-440068

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Pain (1994)

Event Date 04/16/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: foreign - (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient was revised approximately 10 months post initial procedure due to heel pain.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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.

Event Description

No additional event information is available at the time of this report.

• Brand Name: PHOENIX 5MM SCREW AND ENDCAP
• Type of Device: TRAUMA IMPLANT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11712272
• MDR Text Key: 247465417
• Report Number: 0001825034-2021-01214
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 07/14/2021

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 Catalogue Number: 14-440068
• Device Lot Number: UNKNOWN
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/13/2021
• Initial Date FDA Received: 04/22/2021
• Supplement Dates Manufacturer Received: 06/17/2021
• Supplement Dates FDA Received: 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention