MAUDE Adverse Event Report: BIOMET 3I TITANIUM HEXED UNISCREW; DENTAL SCREW

Model Number	UNIHT
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Age and date of birth unknown / not provided.Patient sex unknown / not provided.Weight unknown / not provided.Date of the event unknown / not provided.Reporter name was not provided.No product returned.
Event or Problem Description
The screw uniht fracture.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).The titanium hexed uniscrew (uniht) was not returned.Since product has not been returned, visual/functional evaluation could not be performed.The investigation has been performed based on the available information.The reported event could not be recreated due to the nature of the dental device and event (fracture).The customer has provided additional pictures of the product.It can be seen that the screw is fractured at the intersection between the threads and collar.Device history record (dhr) review was completed for the subject lot number 1166606-cn.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 was performed for the reported lot number (1166606-cn) for similar event and 1 other complaint was identified.Therefore, based on the available information, device malfunction has occurred and the reported event was confirmed.

• Brand Name: TITANIUM HEXED UNISCREW
• Common Device Name: DENTAL SCREW
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10244431
• Report Number: 0001038806-2020-00953
• Device Sequence Number: 14251709
• Product Code: NHA
• UDI-Device Identifier: 00844868017318
• UDI-Public: (01)00844868017318(17)181025(10)1166606-CN(241)UNIHT
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K072642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2020

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: 10/25/2018
• Device Model Number: UNIHT
• Device Catalogue Number: UNIHT
• Device Lot Number: 1166606-CN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/19/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 07/08/2020
• Supplement Report FDA Received Date: 10/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1