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

Model Number	HX12.5
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Patient identifier unknown / not provided.
Event or Problem Description
Upon investigation it has been determined that there is a fracture and after a follow-up with the doctor, he confirmed that the tip broke while unscrewing the implant mount.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).One tool hex sst 1.25mm 22mm (hxl1.25) was returned for investigation.Visual evaluation of the as returned product identified that the tip was twisted/damaged and fractured.Device history record (dhr) review could not be performed since the lot number associated to the item was not provided.However, zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product.A complaint history review by item number was conducted for the hxl1.25 dating back to 12 months from now.The complaint history review revealed that there are no existing non-conformances/capa/hhe/d/ie/product holds for the reported product for similar events (complaint category keyword: functional: damaged drive feature & fracture).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 22MM
• Common Device Name: DENTAL INSTRUMENT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 12369102
• Report Number: 0002023141-2021-02290
• Device Sequence Number: 5413991
• Product Code: NDP
• UDI-Device Identifier: 00889024015371
• UDI-Public: (01)00889024015371(17)991231(10)2018101263
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2021

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 Expiration Date: 10/19/2023
• Device Model Number: HX12.5
• Device Catalogue Number: HXL1.25
• Device Lot Number: 2018101263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/02/2021
• Supplement Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 08/26/2021
• Supplement Report FDA Received Date: 10/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 81