MAUDE Adverse Event Report: SYNTHES USA; APPLIANCE, FIXATION, NAIL

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

Patient Problems Unspecified Infection (1930); Thrombosis (2100); Impaired Healing (2378); Post Operative Wound Infection (2446); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device used for treatment, not for diagnosis.H10: additional narrative: b3: zemen, j; matejka, j (2005) the use of synthes hybrid external fixator for the treatment of tibial fractures.Acta chirurgiae orthopaedicae et traumatologiae chechosl, 72: 337-343.D1, d2, d3: this report is for an unknown external hybrid fixator (unknown quantity/unknown lot).D4: (other number) udi: unknown part number, udi is unavailable h3, h6: 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.H6: 3191 for range of movement limited by 15 degrees, 3 had significant movement reduction of the knee or ankle joint.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 article: zemen, j; matejka, j (2005) the use of synthes hybrid external fixator for the treatment of tibial fractures.Acta chirurgiae orthopaedicae et traumatologiae chechosl, 72: 337-343.The study deals with treatment of the articular ends of the tibia, using a hybrid external fixator.A group of patients treated in the years 2001¿2003 is retrospectively evaluated.Twenty-one patients (16 men and 5 women) with a fracture of either the distal or the proximal end of the tibia were treated, using a synthes external hybrid fixator, at the department of orthopedics and traumatology, faculty of medicine, charles university, plzen.The average age of the patients was 49.2 years.The fractures, evaluated by the ao classification.Included five type a3 fractures and 16 type c1 or c2 fractures.In 14 patients the fracture was associated with multiple trauma or polytrauma and in seven it was a single injury.Open fractures were treated in five patients (grade 2 in two and grade 3 in three patients), closed fractu res in 16 patients (type cii in 12 and type ciii in four patients, as assessed by tscherne's classification).Fifteen patients had fracture of the proximal tibia and six had distal tibial fracture.A hybrid external fixator was used alone in six patients, and in combination with miniosteosynthesis in 15 patients.Five (26%) were only partially content, they were forced to limit their sport activities, they changed jobs.In this group we noticed that the range of movement was limited by more than 15 degrees.The result was assessed as satisfactory.Three (16%) patients we not happy, there was significant reduction of movement of the knee or ankle joint, post-traumatic arthrosis developed.The result of the treatment is assessed as poor.We detected infection complications in eight cases (42%) ¿ in six cases (32%) it was a superficial ¿pin infection¿ and only in two cases (10%) it was a deep wound infection with the formation of soft tissue defects.After the infection was controlled, these defects were dealt with in cooperation with a plastic surgeon, who covered the defect with a musculocutaneous flap.In both cases the defect originated on the basis of anaerobic infection.In the post-operative period in four cases (21%) we came across deep vein thrombosis, even despite the preventive administration of low-molecular heparin and early mobilization.Two patients (10%) underwent repeat operation.One patient (5%) due to a tibial false joint 6 cm above the ankle joint - in this case internal osteosynthesis with a predrilled intramedullary nail with decortication was performed.The other patient underwent repeat operation 2 weeks after the primary treatment due to the penetration of kirschner wires into the ankle joint.It constituted a technical error during the primary intervention, when reduction and miniosteosynthesis of tibial lower end were not performed and the wires were inserted too low and penetrated the joint.After osteosynthesis of tibial posterior edge and correct mounting of another ef with the bridging of the ankle joint, the fracture healed.All patients started to exercise the adjoining joint immediately after the operation and attachment of hef, actively as well as passively.In 20 patients we achieved at least 75% range of movement during the first 4 weeks after the operation.A copy of the literature article will be submitted with the medwatch.This 1 of 1 for com-277761.This report is for an unknown external hybrid fixator and refers to the serious injury of 5 unknown patients who experienced range of movement limited by 15 degrees, 3 had significant movement reduction of the knee or ankle joint, 6 superficial pin infection, 2 with deep wound infection, 4 with dvt¿s, 2 had repeat operations.

• Type of Device: APPLIANCE, FIXATION, NAIL
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6513371
• MDR Text Key: 73416788
• Report Number: 2520274-2017-11457
• Device Sequence Number: 1
• Product Code: KTT
• 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: 04/06/2017

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: 04/06/2017
• Initial Date FDA Received: 04/21/2017
• 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