MAUDE Adverse Event Report: ZIMMER BIOMET, INC. AFFIXUS HFN 125 DEG 11MM X 180MM; ROD, FIXATION

Model Number N/A

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has not yet indicated if the product will be returned 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 is reported that during the procedure, the sterile packaging of the nail was found to be opened.Another back up nail was available to successfully complete the procedure.No patient consequences were reported as a result of the malfunction.

Manufacturer Narrative

The complaint sample was evaluated and the reported event was confirmed through physical evaluation.The returned product and packaging confirmed that the inner packaging was not sealed, however, showed evidence by the seal marks that the packaging was sealed at some point.The device history records were reviewed and no discrepancies were identified.Upon further review, the root cause of the reported issue was identified as inadequate guidance at the distribution centers to process the returned products.A corrective action has been initiated to address this issue.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.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

The complaint sample was evaluated and the reported event was confirmed through physical evaluation.The returned product and packaging confirmed that the inner packaging was not sealed, however, showed evidence by the seal marks that the packaging was sealed at some point.The device history records were reviewed and no discrepancies were identified.The root cause was determined to be inadequate work procedures/instructions and distribution not integrated into the company¿s quality management system.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

Additional product information received.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.(b)(4).

• Brand Name: AFFIXUS HFN 125 DEG 11MM X 180MM
• Type of Device: ROD, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7895254
• MDR Text Key: 120977235
• Report Number: 0001825034-2018-09036
• 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,distri
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 814311180
• Device Lot Number: 287720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1