MAUDE Adverse Event Report: BIOMET 3I UNKNOWN DRIVER

Model Number N/A

Device Problem Separation Failure (2547)

Patient Problem Osteolysis (2377)

Event Date 09/28/2018

Event Type  Injury  

Manufacturer Narrative

This report is being submitted to report (b)(4).Concomitant medical products: osseotite® tapered certain® prevail® implant 5/4 x 8.5mm, item #: xiitp5485, lot #: 2016120172.The following information is unknown at the time of this report: product code: unknown.Device manufacture date? unknown.The device has been received for evaluation.Investigation has not yet begun.Once the investigation has been completed, a follow up medwatch will be submitted.

Event Description

It was reported that the driver does not release from the implant.The patient was given a graft and will return for a new implant.Bone loss was reported.

Manufacturer Narrative

This report is being submitted to relay corrected information.Additional information has been received from the customer.The driver that was received with the implant was from the implant removal kit to remove the implant, there was no malfunction with the unknown driver.The reported unknown driver no longer meets the requirements to submit a medwatch report.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

Additional information has been received from the customer.The driver that was received with the implant was from the implant removal kit that they used to remove the implant, there was no malfunction with it.The implant was only being removed due to bone loss.

• Brand Name: UNKNOWN DRIVER
• Type of Device: DRIVER
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 8658365
• MDR Text Key: 146655369
• Report Number: 0001038806-2019-00468
• Device Sequence Number: 1
• Product Code: NDP
• 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: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 07/29/2019

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 Model Number: N/A
• Device Catalogue Number: UNKNOWN DRIVER
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/06/2019
• Initial Date FDA Received: 05/31/2019
• Supplement Dates Manufacturer Received: 07/29/2019
• Supplement Dates FDA Received: 07/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR