MAUDE Adverse Event Report: BIOMET 3I ANGLED SCREW CHANNEL DRIVER TIP 30MM; DENTAL TOOL (DRIVER)

Model Number	ASCDT30
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Concomitant device: bnst515, 3i t3® with dcd® non-platform switched tapered implant 5 x 15mm- lot# 2017101050.Concomitant device: unknown competitor torque wrench- unknown lot number.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the driver broke at the tip when the restorative dentist tried to insert restoration.Restoration was completed.The procedure was completed with the same implant,.
Event or Problem Description
No additional event information at the time of this report.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.The following sections are being reported:.H6: type of investigation code was added: 3331, 4110 and 4111.H6: investigation findings code was added: 3252.H6: investigation conclusions codes were added: 4307.One angled screw channel driver tip 30mm, (ascdt30) was returned for investigation.Visual evaluation of the as returned product, identified that the tip was fractured.Functional testing could not be performed, since the product was fractured.No pre-existing conditions were noted, on the per.Procedure was being performed on tooth (b)(6) when the incident occurred.Per the applicable ifu, it is stated, that surgical instruments and instrument cases are susceptible to damage for a variety of reasons, including prolonged use, misuse, and rough or improper handling.Care must be taken to avoid compromising their performance.Dhr review for the lot (1238271) 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.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (1238271), for similar events (complaint category keywords: fracture).And no other complaint was identified.October post market trending was reviewed, and there were no actionable events or corrective actions for the reported event or product.Therefore, based on the available information, device malfunction did occur.And the reported event was confirmed.

• Brand Name: ANGLED SCREW CHANNEL DRIVER TIP 30MM
• Common Device Name: DENTAL TOOL (DRIVER)
• 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: 12291414
• Report Number: 0001038806-2021-01461
• Device Sequence Number: 14404525
• Product Code: NDP
• UDI-Device Identifier: 00844868044024
• UDI-Public: (01)00844868044024(17)250810(10)1238271
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2021

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: ASCDT30
• Device Catalogue Number: ASCDT30
• Device Lot Number: 1238271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2021
• Supplement Date Received by Manufacturer: 12/20/2021
• Initial Report FDA Received Date: 08/06/2021
• Supplement Report FDA Received Date: 12/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL IMPLANT.; DENTAL TOOL.
• Patient Sex: Female