MAUDE Adverse Event Report: BIOMET 3I CERTAIN® RATCHET EXTENSION - LONG 3.4MM(D); DENTAL RATCHET EXTENSION

Model Number	IIPDTUS
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).Weight unknown / not provided.Email address unknown / not provided.
Event or Problem Description
It was reported that the implant could not be disengage from the implant during its placement.Procedure was completed using a different implant and driver.
Additional Manufacturer Narrative
Zimmer biomet complaint cmp-(b)(4).
Event or Problem Description
No further event information is available at the time of this report.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).The following sections have been updated: b4: date of this report.B5: describe event or problem.G3: date received by manufacturer.H1: type of report, follow-up number.H2: follow up type.H3: device evaluated by manufacturer: change ¿no' to 'yes'.H6: evaluation codes.One certain® ratchet extension - long 3.4mm(d) (imre200) was returned for investigation.Visual evaluation of the as returned products identified that they were engaged.There was signs of wear on the device.Functional testing to recreate the reported event was performed and the device could not be disengaged.Pre-existing condition noted in the per was 'moderate bone density- type ii'.The implant was being placed on tooth 14 (fdi) when the incident occurred.Dhr review could not be performed for the imre200 since the lot number was not provided.However, zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming products.A complaint history review by item number was conducted for the imre200 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 for similar events (complaint category keyword: functional: does not disengage/release).September post market trending was reviewed and there were no actionable events or corrective actions for the reported event or products.Therefore, based on the available information, device malfunction did occur and the reported event was confirmed.

• Brand Name: CERTAIN® RATCHET EXTENSION - LONG 3.4MM(D)
• Common Device Name: DENTAL RATCHET EXTENSION
• 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: 12172931
• Report Number: 0001038806-2021-01276
• Device Sequence Number: 13851997
• Product Code: NDP
• UDI-Device Identifier: 00844868038887
• UDI-Public: (01)00844868038887(10)1226202(241)IIPDTUS
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: IIPDTUS
• Device Catalogue Number: IMRE200
• Device Lot Number: 1226202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2021
• 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: 06/23/2021
• Supplement Date Received by Manufacturer: 08/12/2021; 11/23/2021
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 08/25/2021; 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Male