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

Model Number IRE200U

Device Problem Mechanical Problem (1384)

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

Event Date 03/11/2022

Event Type  malfunction  

Event Description

It was reported that when torqueing, the ratchet got stuck in the implant damaging the internal hex and threads.Another implant and driver was used to complete the procedure.

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).

Manufacturer Narrative

Zimmerbiomet complaint number (b)(4).The reported device was returned for investigation.Visual evaluation of the returned product identified signs of use.Functional testing to recreate the reported event verified the driver is stuck in the implant and does not disengage.The reported implant was located on tooth # 3 and was placed and removed on the same day.A device history record (dhr)review was performed and no related deviations or non-conformances were noted.Also, a complaint history search was performed using our complaint handling system and there were no related complaints for this product lot.Complainant reported that when torqueing, the ratchet got stuck in the implant damaging the internal hex and threads.The reported complaint was confirmed.A definitive root cause for this complaint could not be determined.The following sections have been updated: d4: expiration date, udi h3: device evaluated by manufacturer: change ¿no' to 'yes' h4: device manufacture date h6: evaluation codes h10: additional narrative.

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: IMPLANT 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: 13903127
• MDR Text Key: 287908721
• Report Number: 0001038806-2022-00434
• Device Sequence Number: 1
• Product Code: NDP
• UDI-Device Identifier: 00844868029960
• UDI-Public: (01)00844868029960(10)1222857
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IRE200U
• Device Catalogue Number: IRE200U
• Device Lot Number: 1222857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: XIITP5410
• Patient Age: 53 YR
• Patient Sex: Male