MAUDE Adverse Event Report: ZIMMER DENTAL RETAINING 2.5MM HEX DRIVE R LONG; IMPLANT PLACEMENT TOOL

Catalog Number RHL2.5

Device Problem Separation Failure (2547)

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

Event Type  malfunction  

Event Description

It was reported that implant was placed and when the hex tool was trying to be removed after use, it could not come out of the implant.We had to remove the implant and replace with a larger diameter.

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).Patient weight unknown / not provided.Date of event unknown / not provided.Brand name unknown / not provided.Lot/serial # unknown / not provided.Device expiration date unknown / not provided.Device udi number unknown / not provided.Email unknown / not provided.First name unknown / not provided.Last name unknown / not provided.Pma/510(k) number unknown / not provided.Device manufacturer date unknown / not provided.

Manufacturer Narrative

The following sections have been updated: b4: date of this report.D1: brand name.D4: catalog number.D4: lot/serial #.G3: date received by manufacturer.G6: checked "follow-up".H2: checked follow-up type.H4: device manufacturer date.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 (1) impl tapered scr-v ha 3.7 mm 3.5mm 8mm (tsvh8) & one (1) retaining 2.5mm hex drive r long (rhl2.5) were returned for investigation.Visual evaluation of the as returned product identified signs of use.Functional testing to recreate the reported event; verified the rhl2.5 was stuck and would not release from the implant.The rhl2.5 hex measured 2.5mm.The driver is for placement only via the fmt.(misuse.) a pre-existing condition noted on the per was unknown bone density type.The reported implant was located on tooth # 30 (universal) and was used, placed and removed on the same day.The length of the driver usage is unknown.The customer did not provide any pictures or x-rays.Appropriate documentation was reviewed.Dhr review was completed for the subject lot numbers (1252605 & 0301747).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 numbers were inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot numbers (1252605 & 0301747) for similar events and no other complaint was identified.November post market trending was reviewed and there were no actionable events or corrective actions for the reported event (does not disengage/release) or product (tsvh8 & rhl2.5).No actionable items have been triggered that will affect complaint handling on our end for this month.Based on the available information, devices malfunction did occur and the reported event was confirmed.However, zimvie has found that the issue raised and investigated through this complaint is related to an unintended use of the device per ifu 8874 rev 5.The 2.5mmd hex drivers (gemlock delivery system) should be used to deliver all tapered screw-vent implants via the fixture mount/transfer.

• Brand Name: RETAINING 2.5MM HEX DRIVE R LONG
• Type of Device: IMPLANT PLACEMENT TOOL
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 16240150
• MDR Text Key: 308124509
• Report Number: 0002023141-2023-00287
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date: 01/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RHL2.5
• Device Lot Number: 0301747
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2003
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Male