MAUDE Adverse Event Report: BIOMET MICROFIXATION PERIOSTEAL ELEVATOR #853; ELEVATOR, SURGICAL, DENTAL

Model Number N/A

Device Problems Crack (1135); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint cmp (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.

Event Description

It was reported that two instruments are cracked and loose.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.A visual examination of the customer provided photographs confirmed that the product is cracked.The product identity was unable to be confirmed as no identifying marks were able to be seen in the customer provided photo.Dimensional evaluations could not be performed due to the product not being returned.Lot identification is necessary for review of device history records, lot identification was not provided.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 is available at the time of this report.

• Brand Name: PERIOSTEAL ELEVATOR #853
• Type of Device: ELEVATOR, SURGICAL, DENTAL
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 11121477
• MDR Text Key: 226289822
• Report Number: 0001032347-2021-00011
• Device Sequence Number: 1
• Product Code: EMJ
• UDI-Device Identifier: 00841036029135
• UDI-Public: 00841036029135
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/03/2021

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: 09-0386
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/16/2020
• Initial Date FDA Received: 01/05/2021
• Supplement Dates Manufacturer Received: 01/22/2021
• Supplement Dates FDA Received: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1