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

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the instrument fractured during sterilization.There was no patient involvement.
Additional 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 or Problem Description
This follow-up report is being submitted to relay additional and/or corrected information.

• Brand Name: CRYER ELEVATOR #40L
• Common Device Name: ELEVATOR, SURGICAL, DENTAL
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9081767
• Report Number: 0001032347-2019-00416
• Device Sequence Number: 3587211
• Product Code: EMJ
• UDI-Device Identifier: 00841036028428
• UDI-Public: 00841036028428
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 08/22/2019
• Supplement Date Received by Manufacturer: 11/15/2019
• Initial Report FDA Received Date: 09/18/2019
• Supplement Report FDA Received Date: 11/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1