MAUDE Adverse Event Report: BIOMET 3I NARROW RIGHT ANGLE LARGE HEX DRIVER TIP 24MM; DENTAL INSTRUMENT

Model Number	RASH3N
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Patient identifier unknown / not provided.Age and date of birth unknown / not provided.Patient sex unknown / not provided.Weight unknown / not provided.Date of the event unknown / not provided.Email address was not provided.
Event or Problem Description
Doctor reported that the patient has swallowed the driver.Patient presented a physical handicap and the position was not good when doctor performed the procedure.The patient went to the hospital and confirmed is fine.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Investigation / results: one narrow right angle large hex driver tip (rash3n) was not returned for investigation.Therefore, visual evaluation could not be performed.The investigation was performed using applicable instruction for use and risk files.Functional testing was not performed since the device was not returned.Pre-existing patient condition reported was physical handicap.Device history record (dhr) review was completed for the subject lot number (1181032).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event were noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (1181032) for similar event and no other complaint was identified.Therefore, based on the available information, device malfunction and the reported event could not be verified as the product was not returned and the exact details of event are non-verifiable.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: NARROW RIGHT ANGLE LARGE HEX DRIVER TIP 24MM
• Common Device Name: DENTAL INSTRUMENT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10640811
• Report Number: 0001038806-2020-01521
• Device Sequence Number: 2630686
• Product Code: NDP
• UDI-Device Identifier: 00844868015260
• UDI-Public: (01)00844868015260(10)1181032(241)RASH3N
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/19/2020
• Device Model Number: RASH3N
• Device Catalogue Number: RASH3N
• Device Lot Number: 1181032
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/14/2020
• Supplement Date Received by Manufacturer: 11/13/2020
• Initial Report FDA Received Date: 10/07/2020
• Supplement Report FDA Received Date: 12/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1