MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HEX DRIVER NECK SLEEVE 5.0MM; DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 09/03/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(udi): (b)(4).Customer has indicated that 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.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.

Event Description

It was reported that the patient has underwent an initial hip arthroplasty on an unknown date.Subsequently, while attempting to fully tighten the screw into the side plate the hex driver broke.No pieces fell into the patient and the device was still used.

Manufacturer Narrative

(b)(4).Updated: b4, b5, g4, h1, h2, h3, h6, and h10.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive 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.

Event Description

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

• Brand Name: HEX DRIVER NECK SLEEVE 5.0MM
• Type of Device: DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9130205
• MDR Text Key: 194378933
• Report Number: 0001825034-2019-04286
• Device Sequence Number: 1
• Product Code: JDO
• Combination Product (y/n): N
• PMA/PMN Number: K140018
• 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: 03/23/2020

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 14-451529
• Device Lot Number: 594190
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/04/2019
• Initial Date FDA Received: 09/27/2019
• Supplement Dates Manufacturer Received: 03/20/2020
• Supplement Dates FDA Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1