MAUDE Adverse Event Report: ZIMMER DENTAL TOOL HEX SST 1.25MM 22MM; DENTAL DRIVER

Model Number	HXL1.25
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).
Event or Problem Description
It was reported that tool hex fractured at the tip of the tool.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).
Event or Problem Description
No further event information is available at the time of this report.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).The following sections have been updated: h3: device evaluated by manufacturer: change ¿no' to 'yes'.One driver was returned for investigation.Visual evaluation of the as returned product identified that the tip was fractured and twisted.Functional testing could not be performed due to the nature of the device and event.Pre-existing patient conditions, tooth location, implantation period, x-ray images are irrelevant to this investigation.Picture evaluation: picture image was not provided.Review of appropriate documentation: document reviewed: instructions for use - zimmer instrument kit system, zimmer dental single patient drills, driva drills, and tools, ifu 8874 rev 5 ¿ 08/19.Information identified: indications, warnings and precautions.Per the applicable ifu, it is stated that surgical instruments are susceptible to damage and wear and should be inspected and cleaned before each use.Dhr review: dhr review for the lot (2020120533) 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.Lot was inspected and passed all acceptance criteria by qa.Complaint history review: complaint history review was performed for the reported lot number (2020120533) for similar events (complaint category keywords: fracture) and no other complaint was identified.Post market trending review: july 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: TOOL HEX SST 1.25MM 22MM
• Common Device Name: DENTAL DRIVER
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 14447144
• Report Number: 0002023141-2022-01228
• Device Sequence Number: 6340189
• Product Code: NDP
• UDI-Device Identifier: 00889024015425
• UDI-Public: (01)00889024015425(10)2020120533
• 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,Followup
• Report Date (Section B): 10/05/2022

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: HXL1.25
• Device Catalogue Number: HXL1.25
• Device Lot Number: 2020120533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2022
• 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: 04/28/2022
• Supplement Date Received by Manufacturer: 08/08/2022; 09/20/2022
• Initial Report FDA Received Date: 05/19/2022
• Supplement Report FDA Received Date: 08/10/2022; 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown