MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM TI CORTEX SCREW SELF-TAPPING 18MM; SCREW,FIXATION,BONE

Catalog Number 404.818

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Sepsis (2067)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2016 following a road accident the patient had fractured the middle third of the thimble of the radius and left ulna.On (b)(6) 2016 the patient underwent an osteosynthesis of the forearm with a titanium plate and screws.On (b)(6) 2016 the patient underwent a revision operation due a rupture of the synthesis and a septic complication.An external fixator was applied, and the fracture healed.This report is for (1) 3.5mm ti cortex screw self-tapping 18mm.This is report 6 of 12 for (b)(4).

• Brand Name: 3.5MM TI CORTEX SCREW SELF-TAPPING 18MM
• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12036708
• MDR Text Key: 260505945
• Report Number: 8030965-2021-05147
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K131186
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 404.818
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention