MAUDE Adverse Event Report: BIOMET 3I HANDPIECE CONNECTOR; DENTAL INSTRUMENT

Catalog Number MDR10

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 03/27/2019

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet (b)(4).Patient identifier age and date of birth unknown / not provided.Patient sex unknown / not provided.Weight unknown / not provided.Lot number, expiration date and unique identifier (udi) number are unknown.Device manufacturer date unknown.

Event Description

It was reported that the implant fell down during surgery because it disengaged from the handpiece connector.Doctor completed the procedure by using another implant with the same instrument.

Manufacturer Narrative

Supplemental medwatch zimmer biomet complaint number (b)(4).The following sections have been updated: b4: date of this report.B5: describe event or problem.G4: date received by manufacturer.G7: type of report, follow-up number.H2: follow up type.H3: device evaluated by manufacturer.H10: additional narrative.One 3i t3® tapered implant 4/3 x 11.5mm (bopt4311) was returned for investigation.The reported handpiece connector (mdr10) was not returned for inspection.Visual inspection of the as returned product identified wear from use about the implant threads and drive feature.Functional testing of the reported product was not performed, as the customer reports that the implant was used with the mdr10, however these two devices are not designed to function together.The bopt4311 implant was found to assemble, retain, and disengage with a mating implant driver tip.The reported product disengaged prior to placement.The customer has not provided additional pictures or x-ray images of the product.Device history record dhr review could not be performed, as the lot number associated with the reported product is not available.A complaint history review by item number was conducted for the mdr10 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.

Event Description

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

• Brand Name: HANDPIECE CONNECTOR
• Type of Device: DENTAL INSTRUMENT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9529928
• MDR Text Key: 176463656
• Report Number: 0001038806-2019-01701
• 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
• Report Date: 03/12/2020

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: MDR10
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/03/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 02/24/2020
• Supplement Dates FDA Received: 03/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1