MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA ARTICULAR SURFACE PROVISIONAL; TEMPLATE

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the provisional was found fractured during sterilization process after a case.All pieces were returned.No adverse events have been reported as a result of this malfunction as there was no patient involvement.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required visual inspection of the returned provisional found signs of repeated use and a fracture in the middle of the instrument.Gouge marks and dents were noted which is indicative of repeated use.The returned provisional has a potential field age of 13 years with an unknown number of surgeries and has been subjected to an unknown number of cleaning/sterilization cycles.Per the packaging insert, even with correct use, instruments should not be expected to last indefinitely.Provisionals are often subject to high loads and/or impact forces which can lead to breakage; therefore, the root cause is attributed to wear and tear.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: PERSONA ARTICULAR SURFACE PROVISIONAL
• Type of Device: TEMPLATE
• 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: 7024060
• MDR Text Key: 92741176
• Report Number: 0001822565-2017-07687
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2017
• 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: 00596103212
• Device Lot Number: 60219549
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2004
• 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