MAUDE Adverse Event Report: BIOMET 3I CERTAIN UNIVERSAL RATCHET EXTENSION IMPLANT DRIVER (LONG); DENTAL DRIVER TOOL

Catalog Number IRE200U

Device Problem Separation Failure (2547)

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

Event Date 10/05/2022

Event Type  malfunction  

Manufacturer Narrative

Multiple mdr reports were filed for this event.Please see associated report: 0001038806-2022-01619.Zimmer biomet complaint number (b)(4).Concomitant medical products: bnst585, 3i t3 with dcd non-platform switched tapered implant 5 x 8.5mm/lot number: 2018121124 customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

The doctor indicated that the driver "licks" (implant does not come off.When the implant was removed, the driver could not be removed.The doctor also used a second driver and managed to remove it.However, this time the implant and driver did not come off strongly.There was a delay to the procedure of about 20 minutes.There was no health hazard, and the re-insertion of the implant has already been completed.

Event Description

No additional event information received at the time of this report.

Manufacturer Narrative

Multiple mdr reports were filed for this event.Please see associated report: 0001038806-2022-01619-1.This report is being submitted to relay additional information and device evaluation.The following sections are being reported: b4: date of this report was updated.D9: device availability and return date was 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 universal ratchet extension implant driver (long) (ire200u), one (1) certain universal ratchet extension implant driver (short) (ire100u) were returned for investigation.Visual evaluation of the as returned product identified signs of use, wear.Damage observed to the ire100u.Debris observed on threads of implant.Based on the evaluation, and functional testing device malfunction has occurred.However, there is no existing nonconformance / capa / hhe/d / ie / product hold against the reported devices that did or could cause or contribute to the reported event.Monthly post market trending review identified no actionable trends or corrective actions for the reported event or devices.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 numbers associated with the reported product (ire100u & ire200u) are 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 (ire100u & ire200u) dating back to 12 months prior to the notification date.The complaint history review revealed that there are no existing non-conformance's/capa/hhe/d/ie/product holds for the reported device related to the reported event.Functional testing to recreate the reported event; verified the ire200u was unable to be removed from the implant.A definitive root cause could not be identified.However, based on the investigation, ifu and risk file review, the most likely causes determined from the investigation are clinician does not follow the recommended protocol for product placement and final seating, and clinician applies force/torque exceeding the recommended value during placement/seating.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.

• Brand Name: CERTAIN UNIVERSAL RATCHET EXTENSION IMPLANT DRIVER (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: 15658555
• MDR Text Key: 306679502
• Report Number: 0001038806-2022-01618
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Non-Healthcare 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: IRE200U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/07/2022
• Initial Date FDA Received: 10/24/2022
• Supplement Dates Manufacturer Received: 02/28/2023
• 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
• Treatment: DENTAL IMPLANT-SEE H10 NARRATIVE
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 49 KG