MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN DRIVER

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 07/05/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 22-300920 lot 261390 arcos sts 20x190 mm, 31-301303 lot 199930 arcos cone trial c std 60 mm, 31-301852 lot 170201 hex drive 3,5 mm, 31-301852 lot 120701 hex drive 3,5 mm.Report source: (b)(6).Multiple mdr's were filed for this event: 0001825034 - 2019 - 03359, 0001825034 - 2019 - 03267, 0001825034 - 2019 - 03360, 0001825034 - 2019 - 03361, 0001825034 - 2019 - 03363.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.

Event Description

After implanting an arcos sts stem the trial cone body was locked on the stem in accordance with the surgical technique.When trying to unlock the trial cone body, the screwdriver broke inside the patient.The stem and trial body was explanted, and an attempt to disengage the trial body was made with a new screwdriver, which also broke.The third attempt yielded another broken driver.A surgical delay of 60 minutes was reported.No further information is available at the time of this reporting.

Event Description

No further information is available at the time of this reporting.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No device was returned for evaluation.Part and lot identification are necessary for review of device history records, neither were provided for the unknown instrument.A definitive root cause cannot be determined.No further information available at the time of this reporting.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: UNKNOWN DRIVER
• Type of Device: DRIVER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8849452
• MDR Text Key: 152907020
• Report Number: 0001825034-2019-03363
• Device Sequence Number: 1
• Product Code: HWR
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 11/06/2019

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: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/05/2019
• Initial Date FDA Received: 08/01/2019
• Supplement Dates Manufacturer Received: 10/24/2019
• Supplement Dates FDA Received: 11/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention