MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; REAMER

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

Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930); Injury (2348); Non-union Bone Fracture (2369); No Code Available (3191)

Event Date 07/25/2017

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown reamer-irrigator-aspirator (ria) device/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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: metsemakers wj.Et al (2019), reamer¿irrigator¿aspirator bone graft harvesting for treatment of segmental bone loss: analysis of defect volume as independent risk factor for failure, european journal of trauma and emergency surgery, volume 45, pages 21-29, (belgium).The purpose of this study was to conduct a retrospective evaluation of our results with the treatment of segmental bone loss using ria-harvested autologous bone graft.Furthermore, different risk factors for failure of this technique were analyzed.Between june 2008 and march 2015, 72 skeletally mature patients with segmental bone loss due to acute trauma (defect fractures) or non-union (septic/aseptic), who were treated with a bone graft that was harvested using the ria technique were included in the study.There were 49 male and 23 female patients with a mean age of 45.4 years (range, 18-78 years).40 patients underwent a one-stage procedure, 32 patients underwent ria bone graft harvesting in the context of a two-stage procedure (i.E., masquelet technique).In 4 of these cases, ria autologous bone graft material was augmented with an unknown bone morphogenetic protein (bmp)-7 and unknown beta-tricalcium phosphate (tcp).All procedures were performed using an unknown synthes reamer-irrigator-aspirator device.At the time of ria bone graft harvesting, 40 patients had a plate osteosynthesis in situ, 25 a nail osteosynthesis and in 7 patients a combination of both implants were used.All patients were evaluated using post-operative conventional x-ray series that were consistently included in the follow-up.Complications were reported as follows: 33 patients showed no signs of bone healing (non-union) and needed revision surgeries (i.E., distraction osteogenesis, free vascularized fibula grafting or amputation).3 patients had a deep infection at the grafting site after the treatment using ria.These patients had no infection prior to the procedure.2 patients had a proximal femoral fracture after reaming using the ria technique, necessitating surgical treatment using a proximal femoral nail.3 patients showed anterior cortex perforation during the operation (distally) and were treated conservatively.This report is for one (1) device- unknown synthes reamer-irrigator-aspirator (ria) device.This is report 1 of 1 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 ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8667551
• MDR Text Key: 146961055
• Report Number: 8030965-2019-64875
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 05/07/2019

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