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

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/15/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported a screw fractured upon insertion.No adverse events were reported as a result of this malfunction.
Additional 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 or Problem Description
This follow-up report is being submitted to relay additional information.

• Brand Name: TRAUMAONE SYSTEM 2.0X11MM SELF-DRILLING IMF SCREW
• Common Device Name: SCREW, FIXATION, INTRAOSSEOUS
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9375249
• Report Number: 0001032347-2019-00507
• Device Sequence Number: 595284
• Product Code: DZL
• UDI-Device Identifier: 00841036128104
• UDI-Public: 00841036128104
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K983728
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 09/11/2019
• Supplement Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 11/26/2019
• Supplement Report FDA Received Date: 01/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1