MAUDE Adverse Event Report: SYNTHES USA; APPLIANCE,FIXATION,NAIL/BLADE/PLATE COMBO, SINGLE COMPONENT

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

Patient Problems Necrosis (1971); Pain (1994); Ambulation Difficulties (2544); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Broos, p.L.O., vercruysse, r., fourneau, i., driesen, r., stappaerts, k.H.(1998).Unstable femoral neck fractures in young adults: treatment with the ao 130-degree blade plate.Journal of orthopaedic trauma, 12(4), 235-239.This report is for unknown (130-degree blade plate)/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

This report is being filed after the subsequent review of the following literature article.Broos, p.L.O., vercruysse, r., fourneau, i., driesen, r., stappaerts, k.H.(1998).Unstable femoral neck fractures in young adults: treatment with the ao 130-degree blade plate.Journal of orthopaedic trauma, 12(4), 235-239.Belgium.The purpose of this study was to evaluate the clinical outcome of the treatment of unstable femoral neck fractures using the ao 130-degree blade plate.Between 1980 and 1994, thirty-four (34) patients (twenty-four (24) men, ten (10) women) with an unstable intracapsular hip fracture were treated with a 130-degree blade plate in the university hospital gasthuisberg, leuven.Age at injury ranged from nineteen (19) to forty-nine (49) years (mean of thirty-seven (37) years).The mechanisms of injury were fall from a height (twelve (12) patients), traffic accident (eleven (11) patients), sport injury (nine (9) patients), and a simple fall (two (2) patients).Twenty-five (25) patients were treated within twenty-four (24) hours after injury.Four (4) patients were treated between twenty-four (24) and seventy-two (72) hours after injury.Five (5) patients were referred to our hospital more than three (3) days after the accident.One (1) patient, a missionary from (b)(6), arrived in leuven more than ten (10) days after fracture of the hip.Complications: unknown 130-degree blade plate.Two (2) fractures went on to develop stage iii avascular necrosis: one (1) patient was a heavy drinker, who underwent a total hip replacement with good function three years after the index procedure; one (1) patient who was transported at ten (10) days after fracture from (b)(6).Although the implant was removed, the patient has a significant limp and mild pain but has declined any further operative procedures this is report 3 of 3 for (b)(4).

• Type of Device: APPLIANCE,FIXATION,NAIL/BLADE/PLATE COMBO, SINGLE COMPONENT
• 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: 5853802
• MDR Text Key: 51385282
• Report Number: 2520274-2016-13957
• Device Sequence Number: 1
• Product Code: KTW
• 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: Other
• Type of Report: Initial
• Report Date: 07/19/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/19/2016
• Initial Date FDA Received: 08/08/2016
• 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