MAUDE Adverse Event Report: BIOMET 3I INTERNAL CONNECTION UNIVERSAL PLACEMENT DRIVER TIP - LONG; DENTAL DRIVER TIP

Catalog Number IIPDTUL

Device Problem Separation Failure (2547)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).Patient identifier unknown / not provided.Age and date of birth unknown / not provided.Patient sex unknown / not provided.Weight unknown / not provided.Date of event unknown / not provided.Brand name unknown / not provided.Device product code unknown / not provided.Catalog and lot number unknown / not provided title unknown/ not provided.First/given name: unknown / not provided.Last name unknown / not provided.Email address unknown / not provided occupation unknown / not provided.Pma/510(k) number not available.

Event Description

Doctor reported the driver tip is overload.When doctor engaged to the implant is difficult to remove, it get stuck.Doctor used another instrument to finish the procedure.

Event Description

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

Manufacturer Narrative

Zimmerbiomet complaint number: (b)(4).

Manufacturer Narrative

Zimmerbiomet complaint number (b)(4) the following sections have been updated: b4: date of this report b5: describe event or problem g3: date received by manufacturer h1: type of report, follow-up number h2: follow up type h3: device evaluated by manufacturer: change ¿no' to 'yes' h6: evaluation codes h10: additional narrative one internal connection universal placement driver tip - long (iipdtul) was returned for investigation.Visual inspection of the as returned product identified signs of wear from use at the driver tip.Functional testing notes the device still assembles and disassembles as normal with a mating implant (functional testing).Review of appropriate documentation: documents reviewed: zbinstsm rev.B 12/19; torque matrix - internal connection; page 8-9 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.A complaint history review by item number was conducted for the iipdtul 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.February post market trending was reviewed and there were no actionable events or corrective actions for the reported event (stuck components & components do not assemble) or product (iipdtul).Therefore, based on the available information, device malfunction has not occurred and the reported event was unconfirmed.

Event Description

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

• Brand Name: INTERNAL CONNECTION UNIVERSAL PLACEMENT DRIVER TIP - LONG
• Type of Device: DENTAL DRIVER TIP
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11086194
• MDR Text Key: 228672500
• Report Number: 0001038806-2020-02138
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IIPDTUL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1