MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; REAMER

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

Patient Problems Anemia (1706); Bone Fracture(s) (1870); Unspecified Infection (1930); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown synthes reamer-irrigator-aspirator device/unknown lot number.Without the specific part number, the udi number and 510k 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 as no product was received.Investigation summary: the investigation could not be completed; no conclusion could be drawn at the time of filing this report.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 to include the attachment.

Event Description

Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: han f.Et al (2015), reamer irrigator aspirator bone graft harvesting: complications and outcomes in an asian population, injury-international journal of the care of the injured, volume 46, pages 2042-2051, (singapore).The aim of this retrospective study is to investigate the complications and outcomes in the use of the reamer irrigator aspirator (ria) system for bone graft harvesting for the management of non-union in an asian population.Between september 2008 to march 2013, 53 patients (50 males and 3 females) who underwent a total of 57 ria bone graft harvesting procedures were included in the study.44 patients underwent ria due to segmental bone loss with nonunion of fracture, 5 were due to malunion with bone loss and 4 were due to infected non-union.All bone graft harvesting procedures were performed using an unknown synthes reamer-irrigator-aspirator device.The amount of bone graft harvested, blood loss and post-operative pain were measured.The graft and fracture sites were assessed with physical examination and radiographs.Patients were followed up for an average of 23.4 months (range: 3¿65 months) from the date of the first ria procedure.Patients were followed up for union rate as well as complications of the procedure.Complications were reported as follows: 1 patient had an intraoperative complication with a fractured femoral shaft (harvest site) due to thinning of the cortex by the ria harvester.In this patient, femoral implants were removed from the site of ria harvesting at the same sitting prior to the bone harvesting procedure, resulting in stress risers.The patient was treated with a femoral nail fixation and subsequently made a good recovery with complete healing of the fracture.26 patients who underwent bone grafting without revision fixation had an average drop in hemoglobin of 3.01 g/dl (range 0.7¿5.2 g/dl) on the first postoperative day.5 of these patients required blood transfusion for having developed clinical features of anemia.31 patients who underwent bone grafting with revision fixation had an average drop of 3.26 g/dl (range 1.3¿6.0 g/dl) on the first postoperative day.2 of these patients required blood transfusion for having developed clinical features of anemia.7 patients did not achieve union after the first ria surgery.These patients failed to exhibit any progress in healing after 9 months and were offered repeat surgeries.4 of these patients had repeat ria bone grafting procedure done, 3 achieved union after the repeat procedure.2 patients had iliac crest bone grafting done and these patients achieved union.And 1 patient refused any further procedure.1 male patient did not achieve bone union after the repeat ria bone grafting.This patient had positive tissue cultures from intraoperative fracture site specimens and was started on long term intravenous antibiotics after the second bone grafting and revision fixation with an external device.There was no union noted 10 months after control of his infection.He subsequently underwent a third bone grafting procedure with an iliac crest bone graft and bmp-7 insertion.He is still on follow-up upon completion of this study.2 patients had developed donor site superficial soft tissue infection that resolved with oral antibiotics.This report is for one (1) device- unknown synthes reamer-irrigator-aspirator device.This impacted product capturest the following adverse events: intraoperative fracture of the femoral shaft.Blood transfusion due to anemia.Nonunion and had repeat ria or iliac crest bone grafting.Site superficial tissue infection.This is report 2 of 2 for (b)(4).

• Type of Device: REAMER
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 6103142063
• MDR Report Key: 8668699
• MDR Text Key: 147028037
• Report Number: 8030965-2019-64902
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2019
• 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: 05/07/2019
• 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