MAUDE Adverse Event Report: ZIMMER DENTAL 1.25MM HEX TL,LONG GEMLOC; DENTAL DRIVER

Model Number	HXLGR1.25
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Patient identifier unknown / not provided.Age and date of birth unknown / not provided.Gender unknown / not provided.Patient weight unknown / not provided.Device expiration date unknown / not provided.
Event or Problem Description
The doctor reports that the driver has fractured at the tip during the removal of the healing screw.The affected dental position is unknown.The doctor confirms that the procedure was concluded with another driver.
Additional Manufacturer Narrative
It was reported that the driver has fractured at the tip during the removal of the healing screw.One driver (hxlgr1.25 ¿ 1.25 hex tool, long gemloc) was returned for investigation.Visual/physical evaluation of the as returned product identified fractured around the tip.Functional testing could not be performed due to the nature of the device and event.Dhr review for the lot (2022020305) had revealed no deviations nor non-conformances which could have caused or contributed to the reported events.All products were conforming at the time they left zimvie.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot (2022020305) and no similar event or complaint was found.The customer did not submit images for the reported event.Appropriate documentation was reviewed.Therefore, based on the available information, device malfunction did occur, and the reported event was confirmed.No further investigation or 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.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.
Event or Problem Description
The doctor reports that the driver has fractured at the tip during the removal of the healing screw.The affected dental position is unknown.The doctor confirms in the per that the procedure was concluded with another driver.

• Brand Name: 1.25MM HEX TL,LONG GEMLOC
• 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: 16545793
• Report Number: 0002023141-2023-00822
• Device Sequence Number: 14939026
• Product Code: NDP
• UDI-Device Identifier: 00889024015456
• UDI-Public: (01)00889024015456(17)991231(10)2022020305
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: EXEMPT
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2023

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: Other
• Device Model Number: HXLGR1.25
• Device Catalogue Number: HXLGR1.25
• Device Lot Number: 2022020305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2023
• 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: 03/07/2023
• Supplement Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2022
• 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: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic