MAUDE Adverse Event Report: ZIMMER DENTAL TOOL HANDLE SST SQUARE CO NNECTION; DENTAL DRIVER

Catalog Number SSHS

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 07/30/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Patient identifier unknown / not provided.Age and date of birth unknown / not provided.Patient sex unknown / not provided.Weight unknown / not provided.Lot number, udi number and expiration date unknown / not provided.Email address unknown / not provided.

Event Description

It was reported that during the surgery when the doctor was trying to hold the mount to place the implant, the long screw driver disengage and the implant fell down.Doctor completed the procedure using another implant and another driver.

Manufacturer Narrative

Zimmer biomet complaint number (b)(4) one tool handle sst square connection (sshs) and one impl tapered scr-v mtx 3.7mm 3.5mm 11.5mm (tsvb11) system with its mount were returned.Visual inspection of the as returned products identified the retaining pins on the square connection of the sshs were bent and the implant and mount had no signs of damage.Functional testing was performed for the returned products and it was determined that the complaint sshs was not able to hold the implant mount and an in-house sshs was able to retain the mount as normal.Therefore, the event was confirmed as the reported sshs did malfunction and disengage while the tsvb11 did not malfunction as it functioned as intended with an in house compatible device.Device history record (dhr) review and complaint history review could not be performed, as the lot number associated with the reported product is not available.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product within specifications.A complaint history review by item number was conducted for the (sshs) dating back to 12 months from now.Based on the available information, device malfunction did occur for the reported sshs and device malfunction did not occur for the reported tsvb11.While the reported event was confirmed and recreated through functional testing when the complaint sshs was not able to hold the implant mount.

Event Description

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

• Brand Name: TOOL HANDLE SST SQUARE CO NNECTION
• Type of Device: DENTAL DRIVER
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11076326
• MDR Text Key: 223748060
• Report Number: 0002023141-2020-02391
• 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
• Type of Report: Initial,Followup
• Report Date: 05/05/2021

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: SSHS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/02/2020
• Initial Date FDA Received: 12/28/2020
• Supplement Dates Manufacturer Received: 04/19/2021
• Supplement Dates FDA Received: 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1