MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OFFSET END CAP 12X0MM FFSET; TRAUMA, INSTRUMENT

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/26/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign-event occurred in (b)(6).Udi#: (b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.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

It was reported that operation was performed with phoenix nail system.During the procedure, end cap was changed to a bigger size.Subsequently, after explanting the smaller end cap surgeon dropped it in the patient body.Efforts were made to remove the retained end cap; however it remained in the patient body.No additional patient consequences were reported.There was a delay of 20 minutes as a result of this event.

• Brand Name: OFFSET END CAP 12X0MM FFSET
• Type of Device: TRAUMA, INSTRUMENT
• 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: 8920602
• MDR Text Key: 155195190
• Report Number: 0001825034-2019-03334
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K072161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 14-444180
• Device Lot Number: 873960
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2019
• 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
• Patient Age: 44 YR