MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - RIA; REAMER

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

Patient Problems Bone Fracture(s) (1870); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown ria/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:lowe j., et al (2010), complications associated with negative pressure reaming for harvesting autologous bone graft:a case series , journal of orthopaedic trauma , volume 24(1), pages 46-52, jan 2010 (usa) doi: 10.1097/bot.0b013e31819c0ccb.This study presents a case report of 6 patients,who underwent ria bone graft harvesting in the lower extremity long bone injuries,to demonstrate that some patients who undergo reaming of an intact long bone for autologous bone graft without subsequent fixation or protected weight bearing are at risk for fracture.Reamer¿irrigator¿aspirator system ria (synthes, paoli, pa) was used.(case 1) a case of a 45-year-old insulin-dependent male with diabetes presented to our facility with an infection, 1 month after undergoing primary open reduction and internal fixation of a depressed lateral tibial plateau fracture.He underwent multiple debridements, spanning external fixation, and local and systemic antibiotic treatment of methicillin-resistant staphylococcus epidermidis, the patient¿s inflammatory markers returned to normal.He underwent revision of his right tibial plateau fracture using autologous bone graft harvested with ria from the contralateral femur.Bone graft was obtained without difficulty or complication from his left femur using a 12-mm ria reamer head.Eleven days after his revision surgery, the patient stated that he rolled over in bed and felt a ¿¿snap¿¿ in his left thigh.He was unable to bear weight afterward secondary to pain.He denied any other trauma.Radiographs revealed a spiral fracture of the left midshaft femur.The patient underwent antegrade imn fixation with a statically locked antegrade femoral nail postoperatively, the patient returned to prison and was non¿weight bearing on bilateral lower extremities.The patient was seen 4 weeks postoperatively and was doing well.(case 2) a case of a 56-year-old insulin-dependent female with diabetes presented with a persistent subtrochanteric right femur nonunion and broken hardware.She had been non¿weight bearing on both legs for more than a year, as a result, she had significant osteopenia on her radiographs.Her erythrocyte sedimentation rate and c-reactive protein were 54 mm/h and 4.8 mg/dl, respectively.She underwent revision of the nonunion repair with a synthes proximal femoral locking plate, recombinant human bone morphogenetic protein 2 (infuse; medtronic, minneapolis, mn), and an autogenous bone graft harvested from her left tibia using a 12-mm ria reamer to fill in the bony defect and provide viable bone-forming cells.The bone graft was harvested without complication.No ¿¿cortical chatter¿¿ occurred during the reaming process, and there was no obvious penetration of the cortex, while the reamer was passed under fluoroscopic visualization.On postoperative day 5, the patient was discharged home and was allowed toe touch weight bearing.Leg to use the restroom at home, she developed significant pain and could no longer bear weight.Radiographs demonstrated a spiral fracture of the distal tibial shaft the patient underwent imn fixation with a 13-mm tibial nail postoperatively, the patient was non¿weight bearing on bilateral lower extremities.At her 6-month follow-up visit, the left tibia was radiographically and clinically healed.The subtrochanteric right femur fracture nonunion still persisted, and the patient was referred to a reconstruction specialist for a proximal femoral replacement.(case 3) a case of a 44-year-old female underwent ria bone graft harvesting from the right femur for a left distal femoral nonunion.The nonunion was debrided and grafted in the standard fashion.On postoperative day 2, the patient noticed acute pain and deformity of the right thigh while rolling over in her hospital bed.Radiographs demonstrated a spiral midshaft femur fracture.This fracture was stabilized with a 13-mm antegrade femoral nail after passing a 14-mm reamer the right femur fracture went on to an uneventful union.(case 4) a case of a 40-year-old male with bilateral pilon and calcaneus fractures presented 1 year postoperatively with a right pilon fracture nonunion.He had a history of several fractures.For the pilon nonunion, he underwent a staged repair.During the second stage, he underwent plate fixation of the nonunion.The ipsilateral femur was used for harvesting autogenous bone graft using the ria system.The patient had an uneventful postoperative hospital course and was discharged home.2 weeks after discharge, the patient slipped from his couch and fell to the floor, sustaining an intertrochanteric femur fracture on the side that had undergone ria bone graft harvest.The fracture was treated with a cephalomedullary nail.Six weeks after this surgery, both his pilon nonunion and intertrochanteric fracture showed progressive healing and he was asymptomatic despite not following his non¿weight bearing restrictions.(case 5) a case of a 64-year-old female with diabetes with an infected nonunion of the left distal femur was treated with operative debridement, antibiotic-impregnated polymethylmethacrylate spacer placement, intravenous antibiotics, and subsequent definitive fixation with bone grafting.Ria bone graft harvesting of the right femur was chosen to maximize the quantity of bone obtained.Ria reaming head was selected.Because of the patient¿s preexisting osteoporosis and thinning of the anterior femoral cortex, concerns arose about postoperative iatrogenic fracture.Unplanned prophylactic imn of the right femur, and a 15-mm statically locked antegrade femoral nail was inserted.Postoperatively, the patient was allowed to weight bear as tolerated on the right leg and was kept non¿weight bearing on the left.She went on to an eventual union of her infected left distal femoral nonunion and also had an uneventful postoperative course for her prophylactically nailed right femur.(case 6) a case of a 41-year-old female.Presented with a recalcitrant infected atrophic nonunion of a previously open tibial shaft fracture treated with imn.The patient underwent nail exchange and debridement of the nonunion site, and the ipsilateral femur was prepared for antegrade bone graft harvest using the ria system.Upon completion of harvesting the bone graft, it was noted on fluoroscopy that the reamer head had breached approximately 1 cm of the anterior distal femoral cortex.This complication was thought to result from the guidewire position changing as the reamer was withdrawn and advanced, during harvesting of the bone graft.After the initial passing of the reamer, fluoroscopic monitoring of reaming was not done.The patient was placed on toe touch weight bearing precautions postoperatively.During follow-up, the patient was noted to have healed both the distal femoral cortical defect and the tibial nonunion without complication.This is report 3 of 6 for (b)(4).This report is for an unknown synthes reamer irrigator aspiration (ria) (case 3: 44 year old female).

• Brand Name: UNK - RIA
• Type of Device: REAMER
• 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: 8771925
• MDR Text Key: 150417488
• Report Number: 2939274-2019-59075
• Device Sequence Number: 1
• Product Code: HTO
• 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: 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR