MAUDE Adverse Event Report: ZIMMER DENTAL TOOL HEX SST 1.25MM 17MM; DENTAL INSTRUMENT

Model Number	HX12.5
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Patient identifier unknown / not provided.Age and date of birth unknown / not provided.Patient sex unknown / not provided.Weight unknown / not provided.
Event or Problem Description
It was reported that during the procedure the tip of the instrument fractured.Procedure completed with other instrument.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).One hex driver, short, standard (hx1.25) was returned for investigation.Visual evaluation of the as returned product identified that it was twisted and fractured at the tip.Functional testing to recreate the reported event could not be performed since the device was fractured.Pre-existing patient conditions, tooth location, implantation period, x-ray are irrelevant to this investigation.Picture image was not provided by the customer.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 (pages 2 & 3).Per the applicable ifu, under the section (warnings), it is stated that improper technique could cause device failure.Additionally, under (precautions), surgical instruments are susceptible to damage and wear and should be inspected and cleaned before each use.Dhr review for the lot (2018041359) 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 was performed for the lot (2018041359) for similar events and no other complaint was identified.September post market trending was reviewed and there were no actionable trends or corrective actions for the reported event or device.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: TOOL HEX SST 1.25MM 17MM
• Common Device Name: DENTAL INSTRUMENT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10545623
• Report Number: 0002023141-2020-01442
• Device Sequence Number: 11639730
• Product Code: NDP
• UDI-Device Identifier: 00889024015371
• UDI-Public: (01)00889024015371(17)991231(10)2018041359(241)HX1.25
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2020

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 Model Number: HX12.5
• Device Catalogue Number: HX1.25
• Device Lot Number: 2018041359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/27/2020
• Supplement Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 09/17/2020
• Supplement Report FDA Received Date: 12/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1