MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; REAMER

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

Patient Problem Blood Loss (2597)

Event Date 04/26/2018

Event Type  Injury  

Manufacturer Narrative

Patient id/initials and weight are unknown date of event is unknown; april 26, 2018 is the date the literature article was published.This report is for an unknown synthes reaming-irrigator-aspirator (ria)/unknown lot.Part and lot number are unknown; udi number is unknown.Implant date: unknown.Explant date: 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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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: haubruck p.Et al (2018) complications and risk management in the use of the reaming-irrigator-aspirator (ria) system: ria is a safe and reliable method in harvesting autologous bone graft.Plos one.Volume 13, number 4, pages 1 ¿ 14 (germany).This cohort study presents the risk management and complications associated with the clinical use of reaming-irrigator-aspirator (ria) in the largest single-center case series to date.Between january 01, 2010 and december 31, 2016, 341 ria procedures (215 procedures on 193 men and 126 procedures on 113 women) on 306 patients (average age of 54 years) were performed using an unknown synthes reamer/irrigator/aspirator system.The results were reviewed regarding intra-operative complications, post-operative infection, pain, excessive bleeding, fracture and patient satisfaction.According to younger and chapman, complications were classified into major (infection, subsequent fracture and broken surgical instruments; cmp) and minor complications (bleeding requiring blood transfusion (bld) and procedure -related pain persisting (ppp) 4 weeks or longer).Of the 306 patients who underwent ria, 39 were of observed to have developed intra-operative and post-operative complications.Post-op follow-up was done for patients who exhibited ppp to evaluate duration of post-operative pain 1 ¿ 48 months respectively.This report is for the complications reported as follows: a (b)(6) female patient sustained peri-operative hemoglobin loss 3.5 g/dl.This report is for an unknown synthes reaming-irrigator-aspirator (ria).This report is 9 of 10 for (b)(4).

• Type of Device: REAMER
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7690770
• MDR Text Key: 114075707
• Report Number: 8030965-2018-55042
• 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: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2018
• 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: 06/21/2018
• 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: 38 YR