MAUDE Adverse Event Report: BIOMET 3I UNKNOWN BIOMET SCREW; RESTORATIVE SCREW

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 11/29/2018

Event Type  Injury  

Manufacturer Narrative

This report is being submitted to report (b)(4).Concomitant medical products: full osseotite® tapered certain® implant 4 x 10mm: item #: ifnt410, lot #: 2015091451.The following information is unknown at the time of this report: patient identifier: not provided.Age or date of birth: date of birth not provided.Weight: not provided.Ethnicity: not provided.Procode: product code unknown.The device is expected for evaluation, but has not yet been received.Once investigation is complete, a follow up medwatch report will be submitted.

Event Description

It was reported that the gold screw broke in the implant at tooth location 7.The dr was unable to retrieve the broken screw from implant.The implant was removed.There was no report of patient injury.The patient will not return to have implant replaced.

Manufacturer Narrative

This report is being submitted to relay additional information.The following sections are being reported: it was reported that the gold screw broke in the implant at tooth location 7.The dr was unable to retrieve the broken screw from implant.The implant was removed.There was no report of patient injury.The patient will not return to have implant replaced.The reported device was returned with the concomitant implant.Visual inspection identified that the screw was found in the internal drive feature of the implant.The reported condition of a screw that broke within the implant and was unable to be retrieved was confirmed.A device history record (dhr) and complaint history review could not be performed for the reported screw as the device item and lot number are unknown.A dhr review was completed for the reported concomitant device.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.A complaint history review was completed for the reported concomitant device for similar cause and no other complaint was identified.A definitive root cause for the reported event could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that the gold screw broke in the implant at tooth location 7.The dr was unable to retrieve the broken screw from implant.The implant was removed.There was no report of patient injury.The patient will not return to have implant replaced.

• Brand Name: UNKNOWN BIOMET SCREW
• Type of Device: RESTORATIVE SCREW
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 8540129
• MDR Text Key: 142796110
• Report Number: 0001038806-2019-00352
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/03/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN BIOMET SCREW
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/25/2019
• Initial Date FDA Received: 04/23/2019
• Supplement Dates Manufacturer Received: 07/03/2019
• Supplement Dates FDA Received: 07/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR