MAUDE Adverse Event Report: BIOMET MICROFIXATION ELEVATOR #301; PERIOSTEAL ELEVATOR, REUSABLE

Catalog Number 09-0257

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/22/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: elevator #301; cat# 09-0257; lot# j20.Report source: (b)(6).Two of item# 09-0257 lot# j20 were returned and verified to complaint.It can be seen that the tip end of the products have fractured in different locations within the working end of the tip.No other indications can be observed that would assist in evaluation.The numbers 21 and 23 respectively have been scratched into the handle of the returned parts, which would have occurred after shipment from zimmerbiomet.Review of the device history record(s) identified no deviations or anomalies during manufacturing.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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2021-00282.

Event Description

It was reported that a patient underwent an initial segment procedure in which the tip of two elevators broke.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: ELEVATOR #301
• Type of Device: PERIOSTEAL ELEVATOR, REUSABLE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: jennifer delaney ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 13051770
• MDR Text Key: 285573258
• Report Number: 0001032347-2021-00580
• Device Sequence Number: 1
• Product Code: EMJ
• UDI-Device Identifier: 00841036028176
• UDI-Public: (01)00841036028176(10)T202870000
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/17/2021

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 Catalogue Number: 09-0257
• Device Lot Number: J20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/14/2021
• Initial Date FDA Received: 12/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1