MAUDE Adverse Event Report: SYNTHES USA TI PROXIMAL TIBIA LISS PLATE 5 HOLES/140MM-RIGHT; NAIL,FIXATION,BONE

Catalog Number 422.300

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

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: unknown when infection began.(b)(4); lot number unknown.Original implant date is unknown.Device is not expected to be returned for manufacturer review/investigation.The surgeon suspected the patient had a post-operative infection at the implant site.Revision surgery was performed to remove the implanted hardware.Subject device has not been received.Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It is reported patient was implanted with a proximal tibia less invasive stabilization system (liss) plate and seven (7) screws on an unknown date to repair a right tibia fracture.On unknown date, patient presented to surgeon with exposed hardware where the plate had broken through the patient¿s skin.Surgeon suspects patient had developed a post-operative infection at the implant site, but was prescribed antibiotics prior to the follow up with surgeon.No infection was present at the time of the follow up visit.Patient was returned to surgery on (b)(6) 2016 where surgeon removed all hardware.It was determined patient bone was significantly healed, no additional hardware was implanted.During the revision surgery, it was noted that the two (2) most distal screws had become cold welded to the plate.Surgeon used a carbide drill to remove the screw heads from these two screws, and then used a hollow reamer to remove the screw shafts from patient bone.Removal of the two (2) screws caused a delay of approximately 20 minutes.Procedure was completed successfully with no further harm to patient.This complaint to address revision due to infection.The screws cold welded to the plate addressed in (b)(4).8 devices in 3 part tabs this report is 1 of 3 for (b)(4).

• Brand Name: TI PROXIMAL TIBIA LISS PLATE 5 HOLES/140MM-RIGHT
• Type of Device: NAIL,FIXATION,BONE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5894035
• MDR Text Key: 52673199
• Report Number: 2520274-2016-14296
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 422.300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/09/2016
• 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
• Patient Age: 70 YR
• Patient Weight: 64