MAUDE Adverse Event Report: SYNTHES USA 2.7MM VA-LOCKING CALCANEAL PLATE LARGE 70MM LEFT; PLATE,FIXATION,BONE

Catalog Number 02.211.405

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

Patient Problems Irritation (1941); Pain (1994); Ulcer (2274); No Code Available (3191)

Event Date 05/31/2016

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: patient height reported as: (b)(6).Additional product code is: hwc.(b)(4).Device is not expected to be returned for manufacturer review/investigation.Patient complained of pain post-operatively and an ulcer on the posterior lateral portion of the affected foot.Revision surgery was performed, and some of the synthes devices were removed.Cultures were sent to confirm infection.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 was reported that on (b)(6) 2016 the patient suffered a traumatic injury to the left calcaneus.Multiple fractures of this left foot were treated with open reduction internal fixation (orif) for the calcaneus and subtalar fusion.Patient was originally implanted with two (2) 6.5mm cancellous screws and two (2) mod foot screws for a subtalar fusion.These four (4) screws were implanted thru the calcaneus bone into the subtalar joint and talus bone for fracture reduction.Also, one (1) 2.7mm variable angle locking plate and eight (8) 2.7mm metaphysical screws were implanted into the left calcaneus bone.Post operatively the patient was suffering from pain and a wound/ulcer on the posterior lateral portion of the left foot.A revision surgery was performed on (b)(6) 2016.During revision surgeon removed the one (1) 2.7mm variable angle locking plate and eight (8) 2.7mm metaphysical screws from the calcaneus bone.Patient was also treated with competitors packing bone void filler with antibiotic cement.Surgeon left in the patient the two (2) 6.5mm cancellous screws and two (2) mod foot screws.The surgeon sent cultures to pathology to confirm presence of infection.Post operatively surgeon intends to return the patient for surgical intervention in six weeks.Revision surgery was completed successfully with no issues.Hospital will retain and dispose of the explanted hardware.This complaint has (4) devices.This report is 1 of 4 for (b)(4).

• Brand Name: 2.7MM VA-LOCKING CALCANEAL PLATE LARGE 70MM LEFT
• Type of Device: PLATE,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: 5726268
• MDR Text Key: 47451021
• Report Number: 2520274-2016-13165
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK131186
• 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: 05/31/2016

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 Catalogue Number: 02.211.405
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/31/2016
• Initial Date FDA Received: 06/15/2016
• 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: 49 YR
• Patient Weight: 91