MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GREATER TROCHANTER FEMORAL NAIL; PROSTHESIS, TRAUMA

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: item# 47249236013; greater trochanter femoral nail; lot# 63948458 (10).Report source: foreign: event occurred in (b)(6).The product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-00033, 0001822565-2020-00133, 0001822565-2020-00134, 0001822565-2020-00135, 0001822565-2020-00136, 0001822565-2020-00138, 0001822565-2020-00140, 0001822565-2020-00142, 0001822565-2020-00143, 0001822565-2020-00144.Product not returned.

Event Description

It was reported that the holes of proximal side of the greater trochanter femoral nail had holes for left side.No patient involvement.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint sample was evaluated and the reported event was confirmed.The visual inspection noted that the holes machined are in an incorrect orientation in relation to the nail.Device history record was reviewed and no discrepancies were found.The root cause is determined to be a manufacturing deficiency.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmerbiomet will continue to monitor for trends.

Event Description

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

• Brand Name: GREATER TROCHANTER FEMORAL NAIL
• Type of Device: PROSTHESIS, TRAUMA
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9580489
• MDR Text Key: 181909731
• Report Number: 0001822565-2020-00141
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00889024096110
• UDI-Public: (01)00889024096110
• Combination Product (y/n): N
• PMA/PMN Number: K083497
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2020
• 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: 47249236013
• Device Lot Number: 63948458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1