MAUDE Adverse Event Report: SYNTHES GMBH 4.5MM TI CORTEX SCREW SELF-TAPPING 40MM; SCREW,FIXATION,BONE

Model Number	414.840
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2015 the patient underwent a stabilization and fixation of fractures following a street accident.There were no problems immediately post-op.The patient had pain and on (b)(6) 2016 it was observed that the fractures had not consolidated.It was advised to remove the implants used for the fixation of the fractures and undergo an arthroscopy of the knee.The position of the fracture fragments were found to be in a good position.There was local ingrowth of scar tissue and irregularity of the tibial surfaces, however there were no meniscal lesions and intact cruciate ligaments.There were no signs of adverse reactions against the implanted metal material.From 2016 the patient was treated with high doses of arcoxia and palexia for the serious pain in the left knee and right hip.This report is for one (1) 4.5mm ti cortex screw self-tapping 40mm.This is report 4 of 10 for (b)(4).This complaint is related to (b)(4).

• Brand Name: 4.5MM TI CORTEX SCREW SELF-TAPPING 40MM
• Common Device Name: SCREW,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12011295
• Report Number: 8030965-2021-05000
• Device Sequence Number: 3096612
• Product Code: HWC
• UDI-Device Identifier: 10886982213709
• UDI-Public: 10886982213709
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K974537
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/08/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 414.840
• Device Catalogue Number: 414.840
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 06/16/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention