MAUDE Adverse Event Report: SYNTHES RARON 3.5MM TI LCP® PROXIMAL HUMERUS PLATE-STANDARD 5H SHAFT/114MM; APPLIANCE, FIXATION, NAIL/BLADE/ PLATE COMBO, SINGLE COMPONENT

Catalog Number 441.903S

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

Patient Problems Post Operative Wound Infection (2446); No Code Available (3191)

Event Date 12/10/2015

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.The date of event was reported as (b)(6) 2015; however, it is unclear if this was the date the infection was confirmed or the date the symptoms began.This report is for one unknown philos augmentation plate.Part and lot numbers were not provided by reporter.It is believed the subject device is still implanted in the patient.The subject device is expected to be returned to the synthes manufacturer for evaluation.(b)(6).(b)(4).Without a lot number the device history records review could not be completed.The subject device has been received and is currently in the evaluation process.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 synthes europe reports an event in (b)(6) as follows: it was reported that a philos study# (b)(4) patient underwent surgery to treat a deep wound infection on (b)(6) 2015.Wound debridement was performed and antibiotics, anticoagulant (clexane), and analgesics were administered.The patient was admitted to intensive care for physiotherapy.The philos plate and associated hardware were implanted on (b)(6) 2015.This complaint is related to a second incident of wound infection and intervention.(b)(4).This report is for one unknown philos augmentation plate.This report is 1 of 2 for (b)(4).

Manufacturer Narrative

Only patient¿s year of birth, 1934, was reported.The subject device is not expected to be returned to the synthes manufacturer for evaluation.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

(b)(4).Manufacturing location: (b)(4).Manufacturing date: october 12, 2015.Expiry date: october 01, 2025.No non-conformance reports were generated during production that would contribute to the complaint condition.The review of the device history record shows that there were no issues during the manufacture of the product that would contribute to the complaint condition.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

It was reported that the patient had an infection on the philos plate and the plate has been removed and the patient received antibiotics.

• Brand Name: 3.5MM TI LCP® PROXIMAL HUMERUS PLATE-STANDARD 5H SHAFT/114MM
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/ PLATE COMBO, SINGLE COMPONENT
• Manufacturer (Section D): SYNTHES RARON; kanalstrasse west 30; raron PA CH394 2; SZ CH3942
• Manufacturer (Section G): SYNTHES RARON; kanalstrasse west 30; raron CH394 2; SZ CH3942
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5357853
• MDR Text Key: 35564817
• Report Number: 2520274-2016-10132
• Device Sequence Number: 1
• Product Code: KTW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK011815
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 441.903S
• Device Lot Number: 9642476
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Weight: 73