MAUDE Adverse Event Report: ZIMMER DENTAL IMP TM 4.1MM MTX FULL,13M; DENTAL IMPLANT

Model Number	TMT4B13
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the trabecular metal implant got broken during surgery.No other implant place, no injury or delay.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Additional 510(k) numbers are k113753 and k112160.
Event or Problem Description
There is no update to the original complaint description provided.
Additional Manufacturer Narrative
An imp tm 4.1mm mtx full, 13mm (tmt4b13) was returned for investigation.Visual inspection of the as returned product identified worn marking due to usage, bone and a fracture at the middle threads.No pre-existing conditions were noted on the per.The reported device was location is #42 and was used same day.Pictures or x-ray images were not provided.Review of appropriate documentation: documents reviewed: instructions for use for tapered screw-vent®, advent® and trabecular metal¿ implants 4869 rev 9 ¿ 10/19.Dhr review: dhr review was completed for the subject lot number (1234592).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review: complaint history review was performed for the reported lot number (1234592) for similar event and no other complaint was identified.Review completed utilizing keywords: fracture : implant.Post market trend review: may post market trending was reviewed and there were no actionable events or corrective actions for the reported event or device.Based on the available information, device malfunction did occur and the reported event was confirmed.Sections updated: b4: date of this report.D9: device availability and product return date.G3: date investigation results were received.G6: type of report and follow up number.H2: follow up type.H3: device evaluated.H6: adverse event problem codes.H10: manufacturer's narrative.

• Brand Name: IMP TM 4.1MM MTX FULL,13M
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 13585664
• Report Number: 0002023141-2022-00474
• Device Sequence Number: 12005371
• Product Code: DZE
• UDI-Device Identifier: 00889024018952
• UDI-Public: (01)00889024018952(17)250218(10)1234592
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K132258
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2022

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 Expiration Date: 02/18/2025
• Device Model Number: TMT4B13
• Device Catalogue Number: TMT4B13
• Device Lot Number: 1234592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2022
• Supplement Date Received by Manufacturer: 08/01/2022
• Initial Report FDA Received Date: 02/23/2022
• Supplement Report FDA Received Date: 08/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2020
• 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
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Weight: 60 KG