MAUDE Adverse Event Report: SYNTHES USA; PLATE,FIXATION,BONE

Device Problems Failure To Adhere Or Bond (1031); Device Operates Differently Than Expected (2913)

Patient Problems Unspecified Infection (1930); Necrosis (1971)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: this report is for unknown proximal humeral lpf philos, synthes /unknown.Quantity/unknown lot.Additional product code: hwc.Wound skin flap necrosis (2) requiring debridement and re-suture.The investigation could not be completed and no conclusion could be drawn, as no device was returned and no lot number or part number was provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Literature article received: this report is being filed after the subsequent review of the following literature article : zhang, c., shi, z., and mei, g.(2015) locking plate versus retrograde intramedullary nail fixation for tibiotalocalcaneal arthrodesis: a retrospective analysis.Indian journal of orthopaedics 2015 mar-apr; 49(2): 227¿232.(b)(4).Purpose of study: we retrospectively reviewed the records of 71 patients who underwent tibiotalocalcaneal arthrodesis (ttca) by retrograde intramedullary nail fixation (rinf) or locking plate fixation (lpf) in our hospital between (b)(6) 2007 and (b)(6) 2010.All patients had a diagnosis of tibiotalar and subtalar joints lesions by ankle and foot weight bearing x-ray, computed tomography, and/or magnetic resonance imaging.The eligibility criteria included severe tibiotalar joint lesions combined with subtalar joint lesions and failure to respond to a fair trial of conservative therapy.Exclusion criteria included active infectious disease, diabetes mellitus, severe congenital bone defects or revision surgery.Fifty four patients were included in the final analysis.Patient demographic: ttca surgery with rinf (n = 32, 18 males [56.3%] and 14 females [43.7%]) or lpf (n = 22, 12 males [54.6%] and 10 females [45.4%]).Mean age at surgery for rinf was 48 ± 11 and lpf was 51 ± 12 years.Type of surgery: 32 patients had retrograde intramedullary nail fixation (rinf) and 22 had locking plate fixation (lpf).Implants used: the implant used in all lpf cases was proximal humeral lpf philos, synthes.Complications reported: bone nonunion (1), revision surgery (1),wound skin flap necrosis (2) requiring debridement and re-suture, superficial wound infections (1) requiring intravenous antibiotics.This is report 1 of 1 for (b)(4).This report is for an unknown proximal humeral lpf philos, synthes.

• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5404208
• MDR Text Key: 37305721
• Report Number: 2520274-2016-10573
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2016
• 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