MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VERSANAIL FEMORAL FLEXIBLE JIG BOLT DRIVER 8MM; DRIVER, PROSTHESIS

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/04/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products- insertion jig bolt, cat#: 211201202 lot#: e28dv4, hfn 130 deg 9mm x 180mm, cat#: 814509180 lot#: 118760, 099480, or 099470, t-handle hudson, cat#: 281001004 lot#: fa7n74, insertion jig 130 degree, cat#: 211201201 lot#: e73dg4.Product has been 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 all associated reports: 0001825034-2018-03815, 0001825034-2018-00494, 0001825034-2018-00495.

Event Description

It was reported that during a femoral nail procedure, the bolt would not release from the nail during removal of the jig.The nail was removed after a 15 minute delay to surgery and the bolt was able to release.During the attempted removal of the bolt, the jig bolt driver fractured.No adverse events have been reported as a result of the malfunction with the fractured driver.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 not confirmed.The visual evaluation revealed that the jig bolt driver was noted to be fractured.The jig was removed from the nail with an allen wrench with minimal effort.Once removed, it was noted that the threads of both the jig bolt and the nail are undamaged, and the bolt and nail are able to assemble and disassemble as expected.Device history record was reviewed and no discrepancies were found.The root cause was unable to be determined.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 FLEXIBLE JIG BOLT DRIVER 8MM
• Type of Device: DRIVER, PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7575796
• MDR Text Key: 110452689
• Report Number: 0001825034-2018-03815
• Device Sequence Number: 1
• Product Code: HWR
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• 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: 01/09/2019

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 Model Number: N/A
• Device Catalogue Number: 281013037
• Device Lot Number: NM1210
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/11/2018
• Initial Date FDA Received: 06/06/2018
• Supplement Dates Manufacturer Received: 01/08/2019
• Supplement Dates FDA Received: 01/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 61