MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - RIA; REAMER

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Blood Loss (2597); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown reamer aspirator irrigator/unknown lot.Part and lot number 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.(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: donders, j.C.E., baumann, h.M., stevens, m.F.And kloen, p.(2016), hemorrhagic-induced cardiovascular complications during reamer¿irrigator¿aspirator-assisted femoral nonunion treatment, journal of orthopaedic trauma, vol.30 (no.9), pages e294-298 (netherlands).The aim of this study is to report this complication and to increase awareness of the potential for cardiac events during a ria procedure.A total of 2 patients (1 female and 1 male) were included in the study.Surgery was performed using reamer irrigator aspirator (ria).The following complications were reported: a (b)(6) year-old woman, during the ria procedure, the noradrenaline dose had been gradually increased to a maximum of 0.1 mcg¿kg-1¿min-1.Toward the end of the ria procedure, the blood pressure dropped to 72/17 mm hg and the heart rate increased gradually from 70/min to 100/min.During the following 15 minutes, the pulse oximetry did not function presumably due to peripheral vasoconstriction while noninvasive blood pressure measurement dropped to a mean pressure of 49 mm hg.Another 500 ml colloids and 84 ml of cell saver blood were given rapidly.The electrocardiogram displayed significant st-segment depressions (>0.1 mv) in lead ii and v and a blood sample revealed a hemoglobin level of 5.2 g/dl.Two packed cells were rapidly transfused, an arterial line placed, and tranexamic acid (1 g) was given.Thereafter, blood pressure, st-segment depression, and heart rate normalized within minutes and the hemoglobin level rose to 11.2 g/ dl.Postoperative troponin t evaluation revealed light elevated levels (maximum 0.021 mcg/l¿normal value in our laboratory is below 0.014 mcg/l).A (b)(6) year-old man, during a ria procedure, the heart rate gradually increased from approximately 100/min to approximately 140/min, then it raised further to a maximum of 160/min.It was noted that the st segment in lead ii and v5 were approximately 0.1 mv depressed.Total estimated blood loss at that time was about 4 l with a high uncertainty because blood that was sucked out through the ria was diluted with the irrigation fluid.Subsequently, 1 l of colloid and 1 l of crystalloids and 4 more units of packed red blood cells were administered, which kept the hemoglobin level at approximately 8 g/dl.Esmolol and later metropolol were titrated, and digoxin was given to decrease heart rate to frequencies of approximately 100/min.The st-segment depression gradually disappeared, and the hemoglobin level stabilized around 8 g/dl.Postoperatively troponin t levels were measured and increased to a maximum of 0.05 mcg/l (normal value in our laboratory is below 0.014 mcg/l).The patient developed a hyperkalemia up to 6 mmol/l supposedly due to the multiple blood transfusions.He was discharged home on postoperative day 3 with a hemoglobin level of 8 g/dl.This report is for an unknown synthes reamer aspirator irrigator (ria).This is report 1 of 2 for (b)(4).

• Brand Name: UNK - RIA
• 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: 8727412
• MDR Text Key: 148966070
• Report Number: 8030965-2019-65588
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2019
• 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
• Date Manufacturer Received: 05/28/2019
• 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: 54 YR