MAUDE Adverse Event Report: BIOMET 3I UNKNOWN 3I DRIVER

Device Problems Detachment Of Device Component (1104); Mechanical Problem (1384)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Email address not provided.Product not returned to manufacturer.

Event Description

Doctor indicated that during the implant placement surgery the implant dropped from the unknown 3i driver.Doctor was able to complete the surgery by placing another implant with the same instrument.

Manufacturer Narrative

The unknown biomet driver was not returned for inspection.However, the implant that was associated with the event was returned and was assembled correctly with the recommended driver from inventory and did not disassemble during testing.No device lot number was provided so a device history record review and a complaint history review could not be performed.Appropriate documentation was reviewed and the following information was identified: document type(s) reviewed: instsm rev.G (12/17) ¿ biomet 3i surgical manual tapered & parallel walled implants information identified: instructions specific to a certain internal connection tapered 4mm or larger diameter implant for the certain internal connection tapered implant, pick up the implant from the surgical tray using the dedicated certain implant placement driver tip.Carry the implant to the mouth facing upward to prevent accidental dislodging.Due to wear, periodic o-ring replacement is required for the certain internal connection driver tip.Certain internal connection driver tips should be inspected for wear before use.See page 64 for additional technical tips.Instrument needed for 5mm(d) x 4.1mm(p), 6mm(d) x 5mm(p) and 4, 5 and 6mm(d) tapered implants: dedicated certain standard driver tip (iipdts or iipdtl) pick-up and delivery of implant care must be taken when inserting the implant placement driver tip into the implant.A very low rpm must be used as you approach the internal connection of the implant with the driver tip to properly align the internal hex of the implant with the external hex of the driver.Press down firmly to engage the implant securely.The complainant reported ¿implant did not assemble with driver.The complaint was non-verifiable as the driver in question was not returned for investigation.However, the implant that was returned assembled correctly with a driver from the lab and did not disassemble during testing.No root cause could be determined for this complaint.The following sections have been corrected: brand name: device brand name unknown / not provided.

• Brand Name: UNKNOWN 3I DRIVER
• Type of Device: DRIVER
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 7298795
• MDR Text Key: 101258922
• Report Number: 0001038806-2018-00156
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• 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: 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/28/2018
• Patient Sequence Number: 1
• Patient Age: 40 YR