MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TROCHANTER FEMORAL NAIL; ROD, FIXATION

Model Number N/A

Device Problems Device Packaging Compromised (2916); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Date 01/19/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).Reporter had indicated that product will be returned.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 a procedure, the packaging of the nail was found to be damaged and looked dirty.Foreign particles were reported to be attached to the implant.The implant was used to complete the procedure.No patient consequences have been reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: complaint sample was evaluated and the reported event was confirmed.From returned product evaluation, it was determined that the poly bag exhibits holes, cloudy areas and no foreign material.Device history record was reviewed and no discrepancies relevant to the reported event were found.The root cause can be attributed to abrasion due to transit.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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.

• Brand Name: TROCHANTER FEMORAL NAIL
• Type of Device: ROD, FIXATION
• 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: 7300735
• MDR Text Key: 101268848
• Report Number: 0001822565-2018-00981
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK083497
• 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,Followup,Followup
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 47249240014
• Device Lot Number: 61245109
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2018
• Initial Date FDA Received: 02/27/2018
• Supplement Dates Manufacturer Received: 05/31/2018; 06/01/2018
• Supplement Dates FDA Received: 06/01/2018; 06/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2009
• 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