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

Model Number	HXL1.25
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number: (b)(4).Age at time of the event unknown / not provided.Gender unknown / not provided.Weight unknown / not provided.A tool hex sst 1.25mm 22mm (hxl1.25) was returned for investigation.Visual inspection of the as returned product identified worn markings due to usage and a fractured tip.Device history record (dhr) review was completed for the subject lot number (2021050030).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (2021050030) for similar event and no other complaint was identified.Based on the available information, device malfunction did occur and the reported event was confirmed.
Event or Problem Description
The doctor reports that the screwdriver broke cleanly during the tightening procedure.The doctor reports that the patient did not suffer any negative impact on his health and that the procedure was concluded with another tool due to investigation results, it was confirmed that the driver tip fractured.

• 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
• 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: 14641332
• Report Number: 0002023141-2022-01419
• Device Sequence Number: 4904667
• Product Code: NDP
• UDI-Device Identifier: 00889024015425
• UDI-Public: (01)00889024015425(17)991231(10)2021050030
• 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: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/09/2022

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 Expiration Date: 05/19/2021
• Device Model Number: HXL1.25
• Device Catalogue Number: HXL1.25
• Device Lot Number: 2021050030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• 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: 05/24/2022
• Initial Report FDA Received Date: 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Sex: Unknown