MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; APPLIANCE, FIXATION, NAIL

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

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Necrosis (1971); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown delta external fixation frame/unknown lot.Part and lot number are unknown; udi number is unknown.Date of implantation is an unknown date between (b)(6) 1991 and (b)(6) 1996.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.(b)(4).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: sirkin m, sanders r, dipasquale t, herscovici d (2004).A staged protocol for soft tissue management in the treatment of complex pilon fractures.Journal of orthopaedic trauma.Volume 18.Number 8 supplement.S32-s38.(usa).Between january 1991 and december 1996, 53 patients (56 fractures) with complex pilon fractures who underwent a staged protocol for soft tissue management were included in the study.There were 36 males and 17 females with a mean age of 37 years (range, 21 to 74 years).Fractures were divided into 2 groups: closed and open injuries.Group i consisted of 34 closed fractures and group ii was composed of 22 open fractures.All fibular fractures were initially treated with either an unknown synthes one-third tubular plate or an unknown synthes 3.5mm dynamic compression plate, depending on the fracture pattern.After completing the initial fibular fracture fixation, the 32 fractures were applied with an unknown synthes delta external fixation frame while the other 24 fractures were applied with a competitor¿s external fixator.Patients were followed until soft tissue swelling disappears to have the surgery performed, generally within 7 to 14 days postinjury.Tibial fixation was then obtained using unknown synthes cloverleaf plate in 48 fractures.In 12 fractures, the unknown synthes cloverleaf plate was augmented anteriorly with a 2 or 3-hole unknown synthes one-third tubular plate.In 8 fractures, they were treated medially with a one-third tubular plate (2 fractures), an unknown synthes 4.5mm dynamic compression plate (3 fractures), an unknown synthes t plate (1 fracture), or an unknown synthes 3.5mm dynamic compression plate (2 fractures).When internal fixation was completed, the external fixator pins are removed, and the pin sites are irrigated and curetted.The patients were then placed in a bulky soft dressing with a posterior splint.Patients were followed-up at 3 weeks after discharge.The patients were instructed with a range of motion activities but were not permitted weight bearing until radiographic healing occurred.All patients were followed for a minimum of 12 months postoperatively, and all wound problems were recorded.The authors did not specify which of the synthes plates were used for these patients.Thus, complications will be reported as follows: (group i, closed pilon) 5 limbs had initial partial-thickness skin necrosis.All were treated with local wound care and oral antibiotics when appropriate.1 patient had chronic draining sinus secondary to osteomyelitis which resolved after fracture healing and metal removal.The hardware was removed, the tibia was superficially debrided, and the osteomyelitis and drainage resolved.The patient eventually required an ankle fusion 2 years after the injury for post-traumatic arthritis.(group ii, open pilon): 2 patients had initial partial-thickness skin necrosis.All were treated with local wound care and oral antibiotics when appropriate.1 patient had wound dehiscence with subsequent osteomyelitis necessitating multiple debridements.The patient was placed on intravenous antibiotics and required hardware removal and re-application of an external fixator.The wounds healed, and the infection was eradicated.1 patient developed severe osteomyelitis in multiple sites in this lower limb and required amputation 5 months post-injury.This report is for an unknown synthes delta external fixation frame.This is report 7 of 7 for (b)(4).

• 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: 8616028
• MDR Text Key: 145251704
• Report Number: 2939274-2019-58099
• 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: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/17/2019

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?: Yes
• Initial Date Manufacturer Received: 04/17/2019
• Initial Date FDA Received: 05/16/2019
• 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