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

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

Patient Problems Unspecified Infection (1930); Irritation (1941); Loss of Range of Motion (2032); Staphylococcus Aureus (2058); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not for diagnosis.Georgiades, c; matejka, j; pavelka, t; houcek, p.(2010) treatment of distal humeral fractures by open reduction and internal lcp-dhp fixation.Achot 77, 479-483.This report is for an unknown plate (unknown quantity/unknown lot).Udi: unknown part number, udi is unavailable.(b)(4).The investigation could not be completed; 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 subsequent review of the following literature abstract: georgiades, c; matejka, j; pavelka, t; houcek, p.(2010) treatment of distal humeral fractures by open reduction and internal lcp-dhp fixation.Achot 77, 479-483.This is a retrospective study between january 2006 and june 2008, with a total of 62 distal humeral fractures (61 patients) were treated in our department, of which 27 were managed by locking compression plate/distal humerus plates (lcp-dhp).The group comprised 15 women and 12 men, with an average age of 53.6 years (range, 18 to 84 years).The most common mechanism of injury was a fall in 24 patients.In two cases, injuries were caused by a car accident and one patient had a fracture as a result of gunshot wounds.Associated musculo-skeletal injuries were diagnosed 5 times.Once in the event of poly-trauma after a fall of 6 meters, ipsilateral fracture of the distal femur was the issue.Two patients were diagnosed with contralateral acetabulum after a car accident injury and two were diagnosed with a fracture of the distal radius on the other side.Fractures were classified according to modified ao classification that corresponds to the concept of the two pillars, based on x-rays in the anteroposterior and lateral projection.Fractures were type c fractures, including all subsets cl - c3.Complete healing was evident within an average of 4 months after surgery.Two patients were indicated for an early removal of implants.One case because of ulnar nerve irritation, paresthesia of 4th and 5th finger and limited range of motion.After extraction of the implants and transposition of the nerve, the condition improved.In the second case, late deep infection with staphylococcus aureus was diagnosed 4 months after the surgery.After removal of the implants, suture, lavage and targeted antibiotic therapy, the infection was eliminated.No complications caused by migration and implant failure were detected.In 2 patients, heterotopic ossification was identified, which had no impact on joint function.Distal humerus fractures are difficult to heal therapeutically, mainly due to anatomy.Lcp-dhp due to its anatomical shape, together with a sufficient selection of implant sizes, presents a good option for fixation of fractures of the distal humerus.This complaint is 1 of 1 for (b)(4).This report is for an unknown lcp-dhp and refers to the serious injury of unknown patients who experienced nerve irritation, paresthesia, limited range of motion, late deep staphylococcus aureus infection and implant removal.

• 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: 5506952
• MDR Text Key: 40543177
• Report Number: 2520274-2016-11640
• 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: Other
• Type of Report: Initial
• Report Date: 03/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2016
• 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
• Date Manufacturer Received: 03/04/2016
• 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