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

Catalog Number IMPDTL

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet (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 event unknown / not provided.Lot number unknown / not provided.Udi not available.Email address unknown / not provided.

Event Description

It was reported that during implant surgery while trying to pick up the implant with the driver it did not engage properly.Doctor used another driver to complete the procedure.

Event Description

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

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).One certain® 3.4mm(d) driver tip ¿ long (impdtl) was returned for investigation.Visual evaluation of the as returned products identified signs of wear on the device due to usage but no apparent signs of malfunction.Functional testing was performed using applicable in-house implant.The driver tip was 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) and no other complaints about nonconforming products were identified.Therefore, based on the available information and functional testing, driver malfunction did not occur and the reported event was unconfirmed.

• Brand Name: CERTAIN 3.4MM(D) DRIVER TIP - LONG
• Type of Device: DENTAL DRIVER
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11320825
• MDR Text Key: 231636406
• Report Number: 0001038806-2021-00253
• 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