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

Model Number	RASH2N
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported that during the surgical procedure the tip of the narrow right angle small hex driver broke.Procedure was completed with another implant.The doctor confirms that the patient did not suffer any impact with his health.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).The following sections have been updated: b4: date of this report b5: describe event or problem g3: date received by manufacturer h1: type of report, follow-up number h2: follow up type h3: device evaluated by manufacturer: change ¿no' to 'yes' h6: evaluation codes h10: additional narrative one narrow right angle small hex driver tip 24mm (rash2n) was returned for investigation.Visual evaluation of the as returned product identified some signs of use.No apparent signs of malfunction.Functional could be performed by using in-house compatible device and the driver functioned as intended.Patient conditions, tooth location and duration of placement are irrelevant to this investigation.Device history record (dhr) review was completed for the subject lot number 1227221.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 was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review by lot number (1227221) was performed for similar events using keyword 'functional fracture' and no other similar complaint was identified.September post market trending was reviewed and there were no actionable events or corrective actions for the reported event (fracture) or product (rash2n).Therefore, based on the available information, device malfunction did not occur and the reported event was unconfirmed.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: NARROW RIGHT ANGLE SMALL HEX DRIVER TIP 24MM
• Common Device Name: DENTAL DRIVE
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 12335439
• Report Number: 0001038806-2021-01552
• Device Sequence Number: 3001949
• Product Code: NDP
• UDI-Device Identifier: 00844868015246
• UDI-Public: (01)00844868015246(17)240420(10)1227221
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2021

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: 04/20/2024
• Device Model Number: RASH2N
• Device Catalogue Number: RASH2N
• Device Lot Number: 1227221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2021
• Supplement Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 08/18/2021
• Supplement Report FDA Received Date: 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown