MAUDE Adverse Event Report: BIOMET 3I CERTAIN 3.4MM(D) DRIVER TIP - LONG; DENTAL INSTRUMENT

Catalog Number IMPDTL

Device Problem Mechanical Problem (1384)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).Patient identifier unknown/not provided.Age and date of birth unknown/not provided.Patient sex unknown/not provided.Weight unknown/not provided.Date of the event unknown/not provided.Additional device information unknown/not provided.Device manufacturer date unknown/not provided.

Event Description

Doctor reported there was a problem of adjustment with the drivers during the procedure.The driver got stuck with the implant and doctor was not able to disengage from the implant, at the end the implant lost the primary stability.Doctor was able to complete the procedure by placing another implant with other instruments.

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).One certain® 3.4mm(d) driver tip - short (impdts) and one certain® driver tip ¿ long (impdtl) were returned for investigation.However, two unknown legacy biomet implants were reported but not returned.Visual evaluation of the as returned products identified no apparent signs of malfunction.Functional testing was performed using applicable in-house implant.The driver tips were able to engage, retain and disengage with the implant as normal.Device history record (dhr) review could not be performed as the lot numbers were not available.However, zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming products within specifications.A year-long complaint history review was performed by items (impdtl & impdts) and no other complaints about nonconforming products were identified.However, complaint history review could not be performed for the implants since the lot/item numbers were unknown.Therefore, based on the available information and functional testing, driver tip malfunction did not occur.

Event Description

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

• Brand Name: CERTAIN 3.4MM(D) DRIVER TIP - LONG
• Type of Device: DENTAL INSTRUMENT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11320518
• MDR Text Key: 231616247
• Report Number: 0001038806-2021-00248
• 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: 05/25/2021

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: IMPDTL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/21/2021
• Initial Date FDA Received: 02/12/2021
• Supplement Dates Manufacturer Received: 05/03/2021
• Supplement Dates FDA Received: 05/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1