MAUDE Adverse Event Report: BIOMET MICROFIXATION CRYER ELEVATOR #40L; ELEVATOR, SURGICAL, DENTAL

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).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 instrument fractured during sterilization.There was no patient involvement.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.The complaint is non-verifiable.The cryer elevator #40l (part# 09-0289, lot# 042516d16) was not returned for investigation and no photos were provided.For these reasons, no visual evaluation or functional testing could be conducted.The dhr for this product was reviewed, no non-conformances were found.There are no indications of manufacturing defects.This is the only complaint regarding the tip fracturing for this part# 09-0289, lot# 042516d16.The most likely underlying cause of the complaint could not be determined.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.

Event Description

This follow-up report is being submitted to relay additional and/or corrected information.

• Brand Name: CRYER ELEVATOR #40L
• Type of Device: ELEVATOR, SURGICAL, DENTAL
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9081767
• MDR Text Key: 159156439
• Report Number: 0001032347-2019-00416
• Device Sequence Number: 1
• Product Code: EMJ
• UDI-Device Identifier: 00841036028428
• UDI-Public: 00841036028428
• 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: 11/22/2019

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: 09-0289
• Device Lot Number: 042516D16
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/22/2019
• Initial Date FDA Received: 09/18/2019
• Supplement Dates Manufacturer Received: 11/15/2019
• Supplement Dates FDA Received: 11/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1