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

Device Problem Failure to Cut (2587)

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Brand name, common device name, procode, mfr, lot #, part #, udi #, 510k: this report is for one (1) unknown synthes reamer/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Reporter: reporters are from both countries: usa and (b)(6).(b)(4).Device evaluated by mfr, manufacture date: 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: quintero a, tarkin s, pape hc (2010), technical tricks when using the reamer irrigator aspirator technique for autologous bone graft harvesting, j orthop trauma, volume 24, pages 42-45, (usa).This report describes technical tricks for using the reamer irrigator aspirator to harvest autologous bone graft from the femur.A total of 20 patients who were treated with an autologous bone graft from the femoral cavity were included in the study.There were 12 males and 8 females with a mean age of 44 years (range, 17-71).These patients were treated with autologous bone from the femoral canal instead of an iliac crest bone graft because they were obese and thereby felt to be at high risk for donor site infection, had previously failed treatment with a bone graft from the iliac crest, or had exhausted their bone supply from this donor site.These patients underwent a minimally invasive strategy for harvesting autologous bone graft with the use of an unknown synthes reamer irrigator aspirator (ria) device.The patients were also managed with revision internal fixation when necessary to improve local biomechanics to encourage bone union and were followed until the union is documented.Complications were reported as follows: eccentric reaming resulted in 2 cases in which the anterior cortex of the distal femur was breached, as noted intraoperatively and confirmed on postoperative imaging.Case 1 involved a (b)(6) woman who underwent this procedure due to an oligotrophic nonunion.During the procedure, the anterior cortex was violated while harvesting bone from the ipsilateral femur through a trochanteric antegrade starting point; despite this, however, there was no fracture in the distal main fragment as noted on the postoperative computed tomography scan.The postoperative orthogonal radiographs and a computed tomography scan were obtained to assess the extent of injury to the reamed femur.The patient¿s postoperative weight-bearing status was subsequently modified from weight bearing as tolerated to touch-down weight bearing with crutch assistance for 4 to 6 weeks to prevent a femur fracture secondary to an iatrogenic stress riser.The patient was closely observed during follow up until there was radiographic and clinical healing of the nonunion.By this time, the patient was not experiencing any adverse sequelae.Case 2 involved a (b)(6) woman in whom the guidewire penetrated the medial condyle into the knee during the second pass of the reamer.The first pass was sent into the middle of the condylar block with a straight guidewire followed by a second pass into the lateral condyle with a prebent guidewire.During the second pass, the reamer tip became lodged and drove the guidewire too far distally into the knee¿s joint space.The postoperative orthogonal radiographs and a computed tomography scan were obtained to assess the extent of injury to the reamed femur.The patient¿s postoperative weight-bearing status was subsequently modified from weight bearing as tolerated to touch-down weight bearing with crutch assistance for 4 to 6 weeks to prevent a femur fracture secondary to an iatrogenic stress riser.The patient was closely observed during follow up until there was radiographic and clinical healing of the nonunion.By this time, the patient was not experiencing any adverse sequelae.1 patient had a complication that required a change in intraoperative management.This case involved a (b)(6) woman.During reaming, a 12-mm ria reamer became lodged in her narrow isthmus during a second pass; the device was finally dislodged after 3 minutes of effort, after which the patient became notably bradycardic and hypotensive (60/40 mmhg).An intraoperative echocardiogram showed that the patient had adequate cardiac valve function, did not have a pulmonary embolus, and was volume-depleted.The patient stabilized after infusing 2500 ml of crystalloids and 4 units of packed red blood cells.This report is for a (b)(6) woman that had the 12-mm ria reamer became lodged in her narrow isthmus during a second pass, device was finally dislodged after 3 mins, after which, the patient became notably bradycardic and hypotensive this report is for one unknown synthes reamer.This is report 4 of 4 for (b)(4).

• 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: 8650487
• MDR Text Key: 146387229
• Report Number: 2939274-2019-58370
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2019
• 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: 27 YR