MAUDE Adverse Event Report: ZIMMER DENTAL; SCREW

Model Number N/A

Device Problem Separation Failure (2547)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device has not yet been returned to manufacturer.

Event Description

It was reported that the head of a screw is stripped and the dentist was unable to remove it from the implant.Old biovent screw that was placed over 20 years ago.

Manufacturer Narrative

This report is being submitted to supplement 0002023141-2018-00798.Date recv'd by mfr: 11jan 2018.The reported condition of the screw hex being stripped and becoming stuck in the implant could not be confirmed.The reported device was not returned for evaluation.A device history (dhr) review and complaint history review could not be completed as the reported device lot number is unknown.A definitive root cause of the reported event could not be determined.Probable causes related to the event include customer error in screw torqueing, tissue interference, and inadequate seating.The customer reported that the screw had been placed for 20 years prior to the event, suggesting the device underwent long- term parafunction.The condition of the device following manufacturing and shipping from the zimmer biomet site could not be verified without relevant dhr information or a physical specimen to review.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product.

Event Description

It was reported that the screw head of an unknown zimmer screw was stripped and unable to be removed from the implant.It was reported that the screw was placed over 20 years ago.There was no report of patient injury.

• Type of Device: SCREW
• Manufacturer (Section D): ZIMMER DENTAL; 6221 el camino real; carlsbad CA 92009
• MDR Report Key: 7872466
• MDR Text Key: 120397153
• Report Number: 0002023141-2018-00798
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1