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

Catalog Number IMPDTL

Device Problem Separation Failure (2547)

Patient Problem No Information (3190)

Event Date 03/12/2020

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet (b)(4).Weight unknown / not provided.Lot number unknown / not provided.

Event Description

It was reported that the driver did not disengage easily from the implants.Implants were placed using a different driver.

Manufacturer Narrative

Zimmer biomet complaint number: (b)(4).The following sections have been updated: b4: date of this report.B5: describe event or problem.G3: date received by manufacturer.G6: type of report.H1: type of reportable event.H2: follow up type.H3: device evaluated by manufacturer.H6: adverse event problem.H10: additional narrative.One certain® implant driver tip - short (iipdts), one certain® implant driver tip ¿ long (iipdtl), one certain® 3.4mm(d) driver tip ¿ long (impdtl) and one certain® 3.4mm(d) driver tip ¿ short (impdts) were returned for investigation.Visual evaluation of the as returned products identified signs of wear on the devices due to usage but no apparent signs of malfunction.Functional testing was performed using applicable in-house implant.The devices were able to engage and disengage with the implant as normal.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 (iipdts, iipdtl, impdtl & impdts) 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.

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 DRIVER
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11257272
• MDR Text Key: 229608816
• Report Number: 0001038806-2021-00147
• 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: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• 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: 01/05/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR