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

Model Number	IRE200U
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Additional 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 or Problem Description
No further event information is available at the time of this report.

• Brand Name: CERTAIN® UNIVERSAL RATCHET EXTENSION IMPLANT DRIVER (LONG)
• Common Device Name: 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
• Report Number: 0001038806-2022-00434
• Device Sequence Number: 4596325
• Product Code: NDP
• UDI-Device Identifier: 00844868029960
• UDI-Public: (01)00844868029960(10)1222857
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2022

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2022
• Supplement Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 03/25/2022
• Supplement Report FDA Received Date: 09/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: XIITP5410
• Patient Age: 53 YR
• Patient Sex: Male