MAUDE Adverse Event Report: . FIB ANATOMIC LOCK LEFT 4H STE; PLATE, FIXATION

Catalog Number 856206004

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign: (b)(6).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 report will be submitted.Product not returned.

Event Description

It was reported an alps fibula anatomic plate was opened during surgery and the consultant wanted to contour it.While contouring the distal tab, it broke in the surgeons possession.There was no impact to patient safety but did result in a small delay in surgery.

Manufacturer Narrative

Device history record was reviewed and no discrepancies were found.Per the surgical technique: bending the distal tab beyond 20 degrees may result in breakage.Continuous bending will also fatigue the tab and cause it to break.From follow up information it is unknown if the plate was bent beyond 20 degrees or not.Therefore, a definitive root cause cannot 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: FIB ANATOMIC LOCK LEFT 4H STE
• Type of Device: PLATE, FIXATION
• Manufacturer (Section D): .; 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: 10374122
• MDR Text Key: 201913516
• Report Number: 0001825034-2020-03088
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K111663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 856206004
• Device Lot Number: 890710
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1