MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VERSANAIL EXTRACTOR BOLT TIBIA/FEMUR; SURGICAL INSTRUMENT

Model Number N/A

Device Problems Device Damaged by Another Device (2915); Material Deformation (2976)

Patient Problem No Information (3190)

Event Date 09/23/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical product - unknown trauma nail, cat#: ni lot#: ni.Customer has indicated that the product will not be returned [unknown location] 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 was reported that during the extraction of a nail, the thread of the nail extractor was damaged and the nail could not be explanted.The surgery was completed with an instrument from another set after a seventy (70) minute delay.No further patient complications were reported.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).This follow-up report is being filled to relay a additional information, which was unknown at the time of the initial medwatch.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

(b)(4).This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch.

• Brand Name: VERSANAIL EXTRACTOR BOLT TIBIA/FEMUR
• Type of Device: SURGICAL INSTRUMENT
• 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: 6964302
• MDR Text Key: 89809849
• Report Number: 0001825034-2017-09172
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 281001023
• Device Lot Number: C6EBD4
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/23/2017
• Initial Date FDA Received: 10/20/2017
• Supplement Dates Manufacturer Received: 10/24/2017; 12/15/2017
• Supplement Dates FDA Received: 11/16/2017; 01/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 29 YR