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

Catalog Number IRE200U

Device Problem Separation Failure (2547)

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

Event Date 06/29/2022

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).Patient weight unknown / not provided.Lot/serial # unknown / not provided.Device expiration date unknown / not provided.Device udi number unknown / not provided.Device manufacturer date unknown / not provided.

Event Description

Dr.Indicated when placing implant due to dense bone had to use the torque wrench to remove it, at that stage the instrument was stuck on the implant and we couldn't remove it.Another same size implant placed.Tooth site # 20.

Event Description

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

Manufacturer Narrative

One (1) certainâ® universal ratchet extension implant driver (long) (ire200u) and one (1) 3i t3â® tapered implant 5/4 x 8.5mm (bopt5485) were returned for investigation.Visual evaluation of the as returned product(s) identified that the driver was stuck inside the implant.Zimvie is not responsible for any damage caused by the clinician's removal of the device.Functional testing to recreate the reported event -the instrument was stuck on the implant, and we couldn't remove it- verified that the driver would not disengage from the implant.A pre-existing condition noted on the per was moderate bone density (type ii).The reported device was located on tooth # 35 (universal) and was implanted/explanted on the same day.The customer did not provide any images for the reported event.Appropriate documentation was reviewed.Dhr review could not be performed since the lot number was not provided.However, zimvie quality management system (qms) has controls in place to ensure the distribution of conforming products.Complaint history review: (unknown lot # for ire200u driver).A complaint history review by item number was conducted for the (ire200u) 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.Dhr review: (bopt5485): dhr review was completed for the subject lot number 2021011302.It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review: (bopt5485): complaint history review was performed for the reported lot number 2021011302 for similar events and no other complaint was identified.October post market trending was reviewed and there were no actionable events or corrective actions for the reported event or product.No actionable items have been triggered that will affect complaint handling on our end for this month.Therefore, based on the available information, device malfunction did occur and the reported event was confirmed as physical evaluation identified the driver would not disengage.

• Brand Name: CERTAIN® UNIVERSAL RATCHET EXTENSION IMPLANT DRIVER (LONG)
• Type of Device: DENTAL DRIVER
• 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: 15098011
• MDR Text Key: 303997535
• Report Number: 0001038806-2022-01130
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 12/30/2022

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/15/2022
• Initial Date FDA Received: 07/25/2022
• Supplement Dates Manufacturer Received: 12/30/2022
• Supplement Dates FDA Received: 12/30/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Sex: Female