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 10/08/2020

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, udi number and expiration date unknown / not provided.Email address unknown / not provided.

Event Description

Doctor reported that during the surgery when 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 sbm 3.7mm 3.5mm 16mm (tsvb16) were returned.Visual inspection of the as returned products identified the retaining pins in the square head of the sshs were pressed to the side and were unable to retain the in-house mount during functional testing.In addition, the implant was returned without the mount with dried blood and bone and no apparent malfunction.Functional testing was performed for the returned products and it was determined that the complaint sshs was not able to hold an implant mount.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.The complaint history review revealed that there are no existing non-conformances/capa/hhe/d/ie/product holds for the reported device related to the reported event.Based on the available information, device malfunction did occur for the reported sshs and device malfunction did not occur for the reported tsvb16.While the reported event was confirmed and recreated through functional testing when the complaint sshs was not able to hold an 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: 11076311
• MDR Text Key: 223739121
• Report Number: 0002023141-2020-02390
• 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

• Date FDA Received: 12/28/2020
• 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
• Date Manufacturer Received: 04/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1