MAUDE Adverse Event Report: ZIMMER DENTAL TORQUE WRCH HEX DRVR 1.25 MMD FOR TW20 & TW30 ADV; DENTAL DRIVE TIP

Catalog Number TW1.25

Device Problem Fracture (1260)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).

Event Description

It was reported that the device fractured during use.No patient impact reported.Procedure was able to be completed using another device.

Event Description

There is no update to the original description provided.

Manufacturer Narrative

One torque wrench hex driver 1.25mmd (tw1.25) was returned for investigation.Visual evaluation of the as returned product identified that the tip was fractured off.Functional testing could not be performed since the device was fractured.Pre-existing patient conditions, tooth location, implantation period and x-ray images are irrelevant to this investigation.Per the applicable ifu, it is stated that surgical instruments and instrument cases are susceptible to damage and wear.Improper technique can cause device failure.Dhr review: dhr review could not be performed since the lot number associated to the item was not provided.However, zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product.Complaint history review: a year-long complaint history review by item number (tw1.25) was performed for similar events and no complaint related to nonconforming products was identified.Post market trending review: december post market trending was reviewed and there were no actionable events or corrective actions for the reported event or product.Therefore, based on the available information, device malfunction did occur and the reported event was confirmed.

• Brand Name: TORQUE WRCH HEX DRVR 1.25 MMD FOR TW20 & TW30 ADV
• Type of Device: DENTAL DRIVE TIP
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10938216
• MDR Text Key: 219310133
• Report Number: 0002023141-2020-02136
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: TW1.25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1