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

Model Number	HXL1.25
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Device expiration date not applicable 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
The doctor indicated a fracture.The tip of the hex driver was broken off.The doctor stopped using that hex driver and used a different hex driver.No patient impact.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.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.The reported event is confirmed following inspection and evaluation.Based on the evaluation, device malfunction has occurred.However/additionally, there is no existing nonconformance/capa/hhe/d/ie/product holds against the reported devices that could cause or contribute to the reported event.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product.Therefore, based on the available information, the products were likely within specifications and likely conforming when they left zimmer biomet.Dhr review was completed for the subject lot number (2019121013).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 (2019121013) for similar event and no other complaint was identified.The reported event could not be recreated due to the nature of the dental device and event and the complaint is related to the functional performance of the device.A definitive root cause could not be identified.However, based on the investigation and risk file review, the most likely cause determined from the investigation is the excessive torque placed on hex tool due to improper surgical procedure or poor case planning and over use or mishandling causing wear.No further investigation and no immediate capa/hhe/d escalation is required, as the complaint investigation did not confirm the product was nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.
Event or Problem Description
No additional event information received at the time of this report.

• Brand Name: TOOL HEX SST 1.25MM 22MM
• Common Device Name: DENTAL TOOL
• 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: 12843408
• Report Number: 0002023141-2021-03338
• Device Sequence Number: 4546860
• Product Code: NDP
• UDI-Device Identifier: 00889024015425
• UDI-Public: (01)00889024015425(17)991231(10)2019121013
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 05/24/2022

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: 2019121013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2021
• Supplement Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 11/19/2021
• Supplement Report FDA Received Date: 05/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown