MAUDE Adverse Event Report: ZIMMER DENTAL ZIMMER DRILL STOP KIT; DENTAL INSTRUMENT

Catalog Number DSKIT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Tissue Injury (4559)

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).

Event Description

The stop system exceeds 1 mm of the indicated length, i used it in a case in which i had the right bone and very controlled with a scanner and i broke the roof of the dental nerve canal, there was no nerve injury but the case was planned to stay one mm from the channel, so i checked the set of stops and saw that they exceeded one mm and then i checked other stops of other heights and the same thing happened in all of them, so the stop system is not well calibrated as it should.

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).The following fields have been updated: b4: date of this report.B5: describe event or problem.D9: device availability.G3: date received by manufacturer.G6: type of report.H1: type of reportable event.H2: follow up type.H3: device evaluated by manufacturer.H6: adverse event problem.H10: additional narrative.Zimvie did not receive one (1) dskit, (zimmer drill stop kit) for evaluation.Visual inspection could not be performed.The investigation has been performed based on the available information using the item number, instructions for use (ifu), and risk management file (rmf).Dhr review by lot number could not be performed, as the item/lot number associated with the reported product is not available.However, zimvie 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 dskit dating back to 12 months from now.The complaint history review revealed that there are no existing non-conformances/capa/hhe/d/product holds for the reported product for similar event.Review completed utilizing keywords: dental : design : other.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was improperly identified drill stop by length.However, a definitive root cause could not be determined because the device was not returned.Therefore, based on the available information, a device malfunction was not established.Without device receipt, the reported event is non-verifiable.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were 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 Description

No further event information is available at the time of this report.

• Brand Name: ZIMMER DRILL STOP KIT
• Type of Device: DENTAL INSTRUMENT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMMER DENTAL; productsurv.specialist@zimvie.; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 18133544
• MDR Text Key: 328075951
• Report Number: 0002023141-2023-03218
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: EXEMPT
• Exemption Number: 5645646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 05/01/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: DSKIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/14/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic