MAUDE Adverse Event Report: BIOMET 3I RIGHT ANGLE SLOTTED DRIVER TIP 30MM

Model Number	RASD6
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported that the driver fractured in the tip.Doctor finished the procedure using other instrument in stock.Tooth location unknown.
Additional Manufacturer Narrative
Zimmer biomet complaint number cmp-(b)(4).One right angle slotted driver tip 30mm (rasd6) was returned for investigation.Visual evaluation of the as returned product identified that it was fractured at the tip.Device history record (dhr) review for the lot (1227610) had revealed no deviations nor non-conformances which could have caused or contributed to the reported event.All products were conforming at the time they left zimmer biomet.Complaint history review was performed for the reported lot (1227610) and no similar event or complaint was found.Therefore, based on the available information, device malfunction did occur and the reported event was confirmed.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: RIGHT ANGLE SLOTTED DRIVER TIP 30MM
• Common Device Name: DRIVER
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10990913
• Report Number: 0001038806-2020-02038
• Device Sequence Number: 3478172
• Product Code: NDP
• UDI-Device Identifier: 00844868015239
• UDI-Public: (01)00844868015239(17)290428(10)1227610(241)RASD6
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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: distributor,foreign
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2021

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 Model Number: RASD6
• Device Catalogue Number: RASD6
• Device Lot Number: 1227610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 12/11/2020
• Supplement Report FDA Received Date: 03/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention