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

Catalog Number HXL1.25

Device Problem Fracture (1260)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/16/2021

Event Type  Injury  

Event Description

It was reported that screw driver fractured when trying to unscrew the transfer and the tip got inside the transfer, which is why implant had to be removed, as well.Patient has been rescheduled for new implant placement.

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).Udi not available.

Event Description

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

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).One imp,tsv,4.7,10,mtx,mg (tsvtwb10) along with mount and one tool hex sst 1.25mm 22mm (hxl1.25) were returned for investigation.Visual evaluation of the as returned mount identified some body damage most likely due to removal attempt and stuck devices.Additionally, tip of driver identified fractured as well.Functional testing was performed.The mount was stuck in the implant and could not be disengaged.Functional testing for driver could not be performed due to nature of event.Device history record (dhr) review for driver could not be performed without lot information.A year-long complaint history review by item number (hxl1.25) was performed for similar events using keyword functional fracture and no complaint about nonconforming products was identified.Therefore, based on the available information, device malfunction did occur and the reported event was confirmed.

• Brand Name: TOOL HEX SST 1.25MM 22MM
• Type of Device: 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: 12802155
• MDR Text Key: 280680820
• Report Number: 0002023141-2021-03243
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: HXL1.25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/25/2021
• Initial Date FDA Received: 11/12/2021
• Supplement Dates Manufacturer Received: 02/17/2022
• Supplement Dates FDA Received: 02/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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 Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female