MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; PLATE, FIXATION, BONE

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

Patient Problems Hematoma (1884); Unspecified Infection (1930); Nerve Damage (1979)

Event Date 03/29/2013

Event Type  Injury  

Manufacturer Narrative

There were 43 boys and 15 girls, with an average age of 9 years (range, 3.6¿15.7 years).Exact date of event is unknown; (b)(6) 2013 is the date the literature article was published.510k: this report is for an unknown 3.5mm plate/unknown lot.Part and lot number 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: abdelgawad a et al (2013).Submuscular bridge plating for complex pediatric femur fractures is reliable.Clinical orthopaedics and related research.Volume 471.Page 2797-2807.(usa).This retrospective study aims to ask whether submuscular bridge plating (sbp) (1) reproducibly leads to union in unstable fractures with a low complication rate, (2) achieves near anatomic alignment and leg length equality (3), is unaffected by age, weight, or location of fracture, and (4) is associated with no or minimal refracture after hardware removal.Between 1999 to 2011, 58 pediatric patients with diaphyseal femoral shaft fractures (60 fractures) treated with sbp were included in the study.There were 43 boys and 15 girls, with an average age of 9 years (range, 3.6¿15.7 years).An unknown synthes 4.5mm stainless steel plate or with built-in anterior curvature was selected (occasionally, an unknown synthes 3.5mm plate was used for small patients).The average patient weight was 35.2 kg (range, 12.7¿71.5 kg).Follow up visits were scheduled around 2 weeks postoperatively for wound check (no radiographs were taken, 6 weeks for assessment of bony healing, 3 months for assessment of gait, strength, and a possible return to sports activity, and 8 to 12 months for discussion about implant removal.Minimum followup was 2.4 months (average, 15.5 months; range, 2.4¿50.6 months).The authors did not specify which type of devices were used for each patient.Thus, complications will be reported as follows: 1 patient developed a postoperative hematoma and deep infection, which responded well to serial debridements, antibiotic bead placement, and eventual hardware removal.3 patients had symptomatic hardware that all resolved after hardware removal.2 patients had a superficial wound infection that responded to oral antibiotic therapy.1 patient had temporary peroneal nerve palsy that resolved spontaneously after 3 months.10 patients had an average leg length discrepancy of 9.9 mm.This report is for an unknown 3.5mm plate.This is report 5 of 6 for (b)(4).

• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 8620580
• MDR Text Key: 145398597
• Report Number: 2939274-2019-58147
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• 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: 04/19/2019
• 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