MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VERSANAIL FEMORAL TROCH ENTRY NAIL R 9MMX38CM; PLATE, FIXATION

Model Number N/A

Device Problem Bent (1059)

Patient Problem No Code Available (3191)

Event Date 05/05/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Product has been returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent a procedure to implant a trochanter nail.During the insertion, the nail bent and needed to be removed from the patient.Another trochanter nail was used to complete the procedure.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Inspection of the returned device revealed that the implant was bent at the distal screw hole.The bend was off by 90° with respect to the print caused due to the additional bend.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.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: VERSANAIL FEMORAL TROCH ENTRY NAIL R 9MMX38CM
• Type of Device: PLATE, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7564789
• MDR Text Key: 109896454
• Report Number: 0001825034-2018-03751
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: PK111663
• 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: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 181409380
• Device Lot Number: DLCB6V
• Other Device ID Number: (01) 00887868020407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 26 YR