MAUDE Adverse Event Report: BIOMET MICROFIXATION POTTS ELEVATOR #2 LEFT; ELEVATOR, SURGICAL, DENTAL

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Product has been received by zimmer biomet and 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 elevator fractured at the tip and became stuck in the patient's gums/teeth and was surgically cut out.No additional patient consequences were reported.
Event or Problem Description
This follow-up report is being submitted to relay additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint was opened because the facility reported the tip of the instrument broke during surgery and had to be surgically removed.The potts elevator #2 left (part# 09-0364, lot# 032615c15 ) was returned for investigation.Visual evaluation showed signs of use as there were minor scratches on the body of the elevator and the tip had fractured off.The complaint is confirmed.The most likely underlying cause of the complaint is that excessive force was used, beyond what the instrument was designed to encounter.The is the only complaint regarding the tip fracturing for the 09-0364 potts elevator #2 left lot 032615c15.For this part (09-0364) and the previous four years (from the notification date), there has been a complaint rate of (b)(4) which is no greater than the occurrence listed in the application fmea.The dhr was reviewed and there are no indications of a manufacturing defects.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.The following fields were updated: b4 updated to reflect date of report.B5 describe event or problem.D10 to reflect product return.G1-2 updated to reflect contact information.G4 date received by manufacturer.G7 updated to reflect type of report and follow-up number.H2 updated to reflect follow-up type.H3 updated to reflect device evaluated.H6 updated to reflect method, results & conclusions.H10 updated to reflect additional narratives/data provided.

• Brand Name: POTTS ELEVATOR #2 LEFT
• Common Device Name: ELEVATOR, SURGICAL, DENTAL
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9225273
• Report Number: 0001032347-2019-00467
• Device Sequence Number: 18874330
• Product Code: EMJ
• UDI-Device Identifier: 00841036028978
• UDI-Public: 00841036028978
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 09-0364
• Device Lot Number: 032615C15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/24/2019
• Supplement Date Received by Manufacturer: 12/09/2019
• Initial Report FDA Received Date: 10/23/2019
• Supplement Report FDA Received Date: 01/06/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention