MAUDE Adverse Event Report: ZIMMER BIOMET, INC. AFFIXUS HFN 130 DEG 13MM X 180MM; ROD, FIXATION

Model Number N/A

Device Problem Mechanical Jam (2983)

Patient Problem No Code Available (3191)

Event Date 06/23/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical product - hfn 130 deg 11mm x180mm, cat#: 814511180 lot#: 944660; hfn 130 deg 11mm x180mm, cat#: 814511180 lot#: 901360.Multiple mdr reports were filed for this event, please see all associated reports: 0001825034-2018-04697; 0001825034-2018-04698; 0001825034-2018-04699.Customer has indicated that the product will not be returned [retained by hospital] to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during the implantation of a hip fracture nail, the set screw would not function properly and was jammed, causing the need to remove the nail from the patient.Two (2) additional nails were tested, and also had jammed set screws.The procedure was successfully completed with a fourth (4) nail, however there was a greater than thirty (30) minute delay to the procedure and the patient's femur required further reaming for a larger size nail.No additional patient consequences have been reported.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was not confirmed.Device history record was reviewed and no discrepancies were found.The root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.A summary of the investigation has been sent to the complainant.A field action was conducted in which zimmer voluntarily removed the reported product from the field due to a higher than anticipated complaint rate for the reported failure.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 further event information available at the time of this report.

• Brand Name: AFFIXUS HFN 130 DEG 13MM X 180MM
• Type of Device: ROD, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7804730
• MDR Text Key: 117856000
• Report Number: 0001825034-2018-04699
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: PK100238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/17/2019

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: 814513180
• Device Lot Number: 970530
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/23/2018
• Initial Date FDA Received: 08/22/2018
• Supplement Dates Manufacturer Received: 01/15/2019
• Supplement Dates FDA Received: 01/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: ZFA 2018-00344
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention