MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN AFFIXUS NAIL; ROD, FIXATION

Model Number N/A

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/07/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported the wrong sided affixus nail was placed into the femur and after an x-ray was taken it was noticed that the nail had penetrated the cortex of the femur distally this creating a fracture.Several unsuccessful attempts were made to remove the nail then a plate was applied to fix the fracture distally with the nail still in place.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected 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.The root cause is determined to be use error as it was identified intraoperatively that the wrong side nail was used.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

No additional information received.

• Brand Name: UNKNOWN AFFIXUS NAIL
• Type of Device: ROD, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8206429
• MDR Text Key: 131721150
• Report Number: 0001825034-2018-11569
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 04/25/2019

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/07/2018
• Initial Date FDA Received: 12/31/2018
• Supplement Dates Manufacturer Received: 04/25/2019
• Supplement Dates FDA Received: 05/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention