MAUDE Adverse Event Report: SYNTHES GMBH 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 70MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number 413.370

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

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), 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 (1) 5.0mm ti locking head screw self-tapping 70mm.This is report 10 of 10 for (b)(4).This complaint is related to (b)(4).

• Brand Name: 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 70MM
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• 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: 12011975
• MDR Text Key: 264512905
• Report Number: 8030965-2021-05009
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 10886982212122
• UDI-Public: 10886982212122
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K000682
• 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: 06/08/2021

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
• Device Operator: Health Professional
• Device Model Number: 413.370
• Device Catalogue Number: 413.370
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/08/2021
• Initial Date FDA Received: 06/16/2021
• 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