MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - CONSTRUCTS: DHS/DCS; APPLIANCE, FIXATION, NAIL

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

Patient Problems Loss of Range of Motion (2032); Injury (2348); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown constructs: dhs/dcs/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

This report is being filed after the review of the following journal article: schatzker j, mahomed n, schiffman k, kellam j (1989), dynamic condylar screw: a new device, journal of orthopaedic trauma, volume 3, pages 124-132, (canada).This prospective study reviewed the use of the dynamic condylar screw (dcs) in the treatment of supracondylar fractures, intertrochanteric fractures, subtrochanteric fractures, nonunions, and malunions in 18 patients (19 femora).18 patients (13 male and five female) with 19 femoral problems, treated over the span of 29 months (january 1986 to may 1988) were included in the study.The average age was 51 years (range 17-82 years).There were 6 supracondylar fractures, 7 proximal femoral fractures, 4 hypertrophic nonunions, 1 distal pseudoarthrosis with a false join, and 1 distal varus malunion.All of the fractures were treated with primary open reduction and internal fixation using an unknown ao dynamic condylar screw.14 fracture limbs were put on continuous passive motion postsurgery.The patients were evaluated at follow-up visits with respect to functional capacity (both subjective and objective) and radiological results.The average length of follow-up was 9 months (range 2-18 months), excluding 1 patient who died of unrelated causes 3 months after discharge.Complications were reported as follows: unknown patients had postoperative complications which included pneumonia, surgical ileus, pulmonary embolus, and a hematoma.(case 5) a (b)(6) year old man had displaced fracture with failure of fixation caused by the patient sustaining a fall at 2 and a half months post-surgery.The patient was revised with another dcs.The fracture subsequently united without further complications.(case 12) a (b)(6) year old man had varus malunion at 10 months postsurgery as a result of malinsertion of the dcs implant at the time of surgery.(case 16 and 17) 2 women had fractures that failed to unite and the side plate portion of the dcs fatigued and fractured in a predictable region at 4 months post-surgery.(case 6) 1 male patient had severe varus and valgus instability and a complete lack of quadriceps.The loss of active knee extension resulted from the damage to his quadriceps muscle at the time of the accident.The patient was revised and at the last follow-up examination, he was pain free, had 0-90 degrees of knee flexion and full passive extension and no longer had any varus instability.(case 7) 1 male patient had impaired walking abilities.The patient lacked 10 degrees of extension.(case 10) 1 male patient had impaired walking abilities.He was able to bear full weight on a stable but markedly shortened leg.His continuing difficulty resulted from the large shoe lift necessary to equalize the leg length discrepancy.This report is for an unknown ao dynamic condylar screw system.This report is for one (1) unk - constructs: dhs/dcs.This is report 9 of 9 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: DHS/DCS
• Type of Device: APPLIANCE, FIXATION, NAIL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10414284
• MDR Text Key: 203658677
• Report Number: 2939274-2020-03567
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2020
• 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?: Yes
• Date Manufacturer Received: 07/23/2020
• 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