MAUDE Adverse Event Report: BIOMET MICROFIXATION TRAUMAONE SYSTEM 2.0X11MM SELF-DRILLING IMF SCREW; SCREW, FIXATION, INTRAOSSEOUS

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/15/2019

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.The user facility is foreign; therefore a facility medwatch report will not be available.Report source ¿ (b)(6).

Event Description

It was reported a screw fractured upon insertion.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint was that the imf screw post snapped off after inserting into patient.One imf screw was returned for the complaint: however the product did not match the description of the reported issue.The product appeared in new, unused condition.Distributor was contacted and could not confirm if the product was a screw from the same set/lot.The returned product was functionally tested and no problems were found.For these reasons, the complaint could not be verified and the most likely underlying cause of this complaint could not be determined.There are no indications of manufacturing defects.For the part #91-5611 and the previous year (from the notification date) there has been a complaint rate of 0.02% which is no greater than the occurrence listed in the application fmea.The dhr of this product could not be reviewed due to the lot number being unknown.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.The following fields were updated: b4 updated to reflect date of report b5 updated to describe event or problem d10 to reflect no information g1-2 updated to reflect contact information g4 date received by manufacturer g7 updated to reflect type of report and follow-up number h2 updated to reflect follow-up type h3 updated to reflect device evaluated h6 updated to reflect method, results & conclusions h10 updated to reflect additional narratives/data provided.

Event Description

This follow-up report is being submitted to relay additional information.

• Brand Name: TRAUMAONE SYSTEM 2.0X11MM SELF-DRILLING IMF SCREW
• Type of Device: SCREW, FIXATION, INTRAOSSEOUS
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9375249
• MDR Text Key: 192638502
• Report Number: 0001032347-2019-00507
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: 00841036128104
• UDI-Public: 00841036128104
• Combination Product (y/n): N
• PMA/PMN Number: K983728
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Type of Report: Initial,Followup
• Report Date: 01/14/2020

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 91-5611
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/11/2019
• Initial Date FDA Received: 11/26/2019
• Supplement Dates Manufacturer Received: 12/16/2019
• Supplement Dates FDA Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1