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

Catalog Number IMPDTL

Device Problem Device Damaged by Another Device (2915)

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

Event Date 02/08/2021

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).

Event Description

It was reported that implant driver was used to finalize placement and internal threads of the implant stripped at tooth location # 14 and had to be removed with trephine.New implant was place at this visit.No injury to patient other than implant being removed.No permanent impairment.Impdtl was reported as the driver tip used when the damage to the implant happened.

Manufacturer Narrative

The following sections have been updated: a3: gender.B4: date of this report.G3: date received by manufacturer.G6: checked "follow-up".H2: checked follow-up type.H10: added manufacturer narrative.

Event Description

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

Event Description

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

Manufacturer Narrative

One 3i t3® tapered implant 6/5 x 11.5mm (bopt6511) was returned for investigation.The reported impdtl driver tip was not returned for inspection.Visual inspection of the as returned product identified signs of damage at the implant internal threads.No pre-existing conditions were noted on the per.The reported product was located on tooth # 14 (universal) and removed the same day as placement.The reported event could not be recreated due to the nature of the dental device and event (damage).The customer has not provided additional pictures or x-ray images of the product.Appropriate documentation was reviewed.Dhr review: (bopt6511).Dhr review was completed for the subject lot number 2020021279.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 was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.(impdtl) - dhr review 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.Complaint history review: (bopt6511) - complaint history review was performed for the reported lot number (2020021279) for similar event and 1 other complaint was identified utilizing keyword(s) -damage- under (b)(4).(impdtl) - a complaint history review by item number was conducted for the impdtl dating back to 12 months from now.The complaint history review revealed that there are no existing non-conformances/capa/hhe/d/ie/product holds for the reported product utilizing keyword(s) -damage-.Based on the available information, device malfunction has occurred and the reported event, as it relates to the returned implant, was confirmed.Functionality of the reported driver could not be verified without device return.

• Brand Name: CERTAIN 3.4MM(D) DRIVER TIP - LONG
• Type of Device: DRIVER TIP
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11457281
• MDR Text Key: 239396617
• Report Number: 0001038806-2021-00409
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: IMPDTL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR