MAUDE Adverse Event Report: BIOMET 3I CERTAIN® UNIVERSAL RATCHET EXTENSION IMPLANT DRIVER (LONG); DENTAL DRIVER

Catalog Number IRE200U

Device Problem Device Damaged by Another Device (2915)

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

Event Date 05/16/2022

Event Type  malfunction  

Event Description

It was reported that when placing the implant, the implant hex was damaged.Another implant was placed to complete the procedure.

Manufacturer Narrative

Zimmerbiomet complaint number (b)(4).Age and date of birth unknown / not provided.Weight unknown / not provided.Lot number unknown / not provided.Udi not available.Title unknown/ not provided.First/given name: unknown / not provided.Last name unknown / not provided.Email address unknown / not provided.Postal code: unknown/ not provided.Telephone number unknown / not provided.

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).H10: additional narrative: a certainâ® universal ratchet extension implant driver (long) (ire200u) was not returned.Since product has not been returned, visual/functional inspection could not be performed.The investigation has been performed based on the available information.Device history record (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 (ire200u) 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 device related to the reported event.Based on the available information, device malfunction could not be verified as the ire200u was not returned however a malfunction did occur with tsvb10 and the reported event was confirmed.

Event Description

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

• Brand Name: CERTAIN® UNIVERSAL RATCHET EXTENSION IMPLANT DRIVER (LONG)
• Type of Device: DENTAL DRIVER
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 14683820
• MDR Text Key: 293936871
• Report Number: 0001038806-2022-00910
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IRE200U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male