MAUDE Adverse Event Report: BIOMET 3I CERTAIN® PREFORMANCE® POST 3.4MM(D) X 3.8MM(P) X 4MM(H); TEMPORARY ABUTMENT.

Catalog Number IMPFP34

Device Problems Separation Failure (2547); Device Damaged by Another Device (2915)

Patient Problem No Information (3190)

Event Date 06/24/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the doctor was tying to remove the temporary abutment (impfp34) in order to place the final restoration with the incorrect hex driver and the screw head became stripped.They were unable to remove the abutment, so they removed the entire implant (bost3211) and placed a new implant and abutment.They hand removed the implant.

Event Description

It was reported that the doctor was tying to remove the temporary abutment (impfp34) in order to place the final restoration with the incorrect hex driver and the screw head became stripped.They were unable to remove the abutment, so they removed the entire implant (bost3211) and placed a new implant and abutment.They hand removed the implant.There have been no new event updates reported at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to supplement initial report.One t3® implant was returned for inspection with a temporary abutment and attached crown.Visual inspection revealed signs of wear at the threads and collar.The crown and abutment were removed using hand tools.The attached screw shows additional signs of wear and some debris.The internal drive feature of the implant contains a significant amount of debris.The abutment tines are noted to be worn and contain additional debris.The reported malfunction cannot be confirmed.No issues were identified during investigation that could have caused or contributed to the reported malfunction.The reported event, "the temporary abutment could not be removed to place the final restoration and that the screw drive feature was damaged, leading to implant removal" could not be recreated.All components were able to be removed with hand tools, and no signs of damage were noted.A device history record review for the reported lot was completed.No unauthorized deviations or non-conformances were noted.The lot was inspected and accepted by quality assurance.Based on inspection of relevant dhr information, the reported devices likely left the zimmer biomet manufacturing site conforming and within specifications.A complaint history review was completed for the reported item and lot.No other complaints were found for the reported condition and lot combination.A definitive root cause of the reported event could not be determined.The most likely probable causes include customer error in driver usage, improper torqueing, and debris caught in the drive feature.

• Brand Name: CERTAIN® PREFORMANCE® POST 3.4MM(D) X 3.8MM(P) X 4MM(H)
• Type of Device: TEMPORARY ABUTMENT.
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 7938585
• MDR Text Key: 122848907
• Report Number: 0001038806-2018-00861
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• PMA/PMN Number: PK053170
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: IMPFP34
• Device Lot Number: 1189500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: CONCOMITANT BOST3211.; CONCOMITANT BOST3211
• Patient Outcome(s): Required Intervention