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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Non-union Bone Fracture (2369); Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Metzl, j.Et al (2013) a clinical and radiographic comparison of two hardware systems used to treat jones fracture of the fifth metatarsal.Foot and ankle international 34(7): 956-61.This report is for unknown screw, unknown quantity, unknown lot.Other number: udi- unknown part number, udi is unavailable (b)(4).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, metzl, j.Et al (2013) a clinical and radiographic comparison of two hardware systems used to treat jones fracture of the fifth metatarsal.Foot and ankle international 34(7): 956-61.Forty-seven patients underwent surgery (47 feet) for a jones fracture between 1999 and 2007, performed by 4 foot and ankle fellowship-trained orthopaedic surgeons at one institution.Twenty-six patients (26 feet) were treated with the indication-specific screw (group i), while 21 patients (21 feet) were operated on with the traditional screw (group ii)--of the traditional screw group, 17 patients were treated with 4.5mm synthes asif malleolar screws and 3 patients treated with 6.5mm synthes asif malleolar screws.The average patient age was 43.8 years of age.One patient in the indication-specific group and 5 patients in the traditional screw group had a preexisting diagnosis of diabetes.Bone graft was added to the fracture in 5 patients in the indication-specific screw group and 4 patients in the traditional screw group.All patients who received bone graft had a delayed union or non union of 3 months or more based on patient history, physical examination and plain radiographs.This is report 1 of 2 for (b)(4).This report is for unknown synthes asif malleolar screw and refers to the following: 2 implant failures (radiographic nonunion both of which went on to hardware failure).

• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6099946
• MDR Text Key: 59795584
• Report Number: 2520274-2016-15371
• Device Sequence Number: 1
• Product Code: HWC
• 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,litera
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/21/2016
• 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