MAUDE Adverse Event Report: BIOMET MICROFIXATION CRANE PICK ELEVATOR; ELEVATOR, SURGICAL, DENTAL

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2019

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).The investigation is in process.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that an instrument fractured during a tooth extraction.The fractured piece of the instrument was removed by suction.No adverse events were reported as a result of this device malfunction.

Event Description

This follow-up report is being submitted to relay additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The customer reported that their 09-0262 crane pick elevator lot number unknown fractured during a case.Functional testing and inspections could not be performed due to the product not being returned.A determination could not be made off of the customer provided photograph.For these reasons, the complaint cannot be verified and the most likely underlying cause cannot be determined.There are no indications of manufacturing defects.For this part (09-0262) and the previous one year there has been a complaint rate of (b)(4), which is no greater than the occurrence listed in the application fmea.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: CRANE PICK ELEVATOR
• Type of Device: ELEVATOR, SURGICAL, DENTAL
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9260380
• MDR Text Key: 192637703
• Report Number: 0001032347-2019-00477
• Device Sequence Number: 1
• Product Code: EMJ
• UDI-Device Identifier: 00841036028237
• UDI-Public: 00841036028237
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/08/2020

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: 09-0262
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/02/2019
• Initial Date FDA Received: 10/31/2019
• Supplement Dates Manufacturer Received: 12/11/2019
• Supplement Dates FDA Received: 01/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1