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

Catalog Number IMPDTL

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/29/2022

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the placement driver was stripped.The bottom hex that engages the implant was stripped.The damage was discovered during a procedure.They were able to complete the procedure with the same implant.

Manufacturer Narrative

This report is being submitted to relay additional information corrected data and device evaluation.Correction: the reported catalog number, iipdtul was corrected/updated to impdtl.The following sections are being reported: b4: date of this report was updated.B5: description of event was updated.D1: brand name was corrected/updated.D4: catalog number was corrected/updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H3: device evaluated by manufacturer was updated.H6: investigation type codes were added: 4109, 4110 and 4111.H6: investigation findings code was added: 180.H6: investigation conclusions codes were added: 4307.H10: narrative/data was updated.One (1) certain 3.4mm(d) driver tip - long (impdtl) was returned for investigation.Visual evaluation of the as returned product identified signs of use.Device was measured with a calliper.Device identified as an impdtl, and malfunction confirmed.The reported device was returned, and the reported event was confirmed following evaluation and functional testing.Based on the evaluation, and functional testing device malfunction did occur.However, there is no existing nonconformance / capa / hhe/d / ie / product hold against the reported device that did or could cause or contribute to the reported event.Monthly post market trending review identified no actionable events or corrective actions for the reported event or device.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product.Therefore, based on the available information, the product was within specifications and conforming when it left zimmer biomet.Dhr review and complaint history review by lot number could not be performed, as the lot number associated with the reported product is not available.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product within specifications.A complaint history review by item number was conducted for the (impdtl) dating back to 12 months prior to the notification date.The complaint history review revealed that there are no existing non-conformances/capa/hhe/d/ie/product holds for the reported device related to the reported event.Functional testing with an in-house implant confirmed that the driver does not grip the implant when torquing.A definitive root cause could not be determined.However, based on the investigation, ifu and risk file, the most likely cause determined from the investigation is failure to follow recommended guidance for usage in surgical manual.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the product was nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.

Event Description

Upon device inspection, the item number associated with this event was updated.

• Brand Name: CERTAIN 3.4MM(D) DRIVER TIP - LONG
• Type of Device: DENTAL DRIVER TOOL
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 15657891
• MDR Text Key: 302285534
• Report Number: 0001038806-2022-01617
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/03/2023

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: 10/03/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/11/2022
• Initial Date FDA Received: 10/24/2022
• Supplement Dates Manufacturer Received: 02/27/2023
• Supplement Dates FDA Received: 03/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1