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U.S. Department of Health and Human Services

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

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OBERDORF SYNTHES PRODUKTIONS GMBH UNK - RIA REAMER Back to Search Results
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Code Available (3191)
Event Date 09/14/2020
Event Type  Injury  
Manufacturer Narrative

510k: this report is for an unknown reamer/unknown lot. Part and lot numbers are unknown; udi number is unknown. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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.

 
Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, a debridement procedure for a suspected infected tissue within the left femur was performed. The surgeon completed the irrigation and then placed the ria ii over the reaming rod through the canal. The surgeon inserted a 2. 5mm reaming rod down the intramedullary canal of the femur using the entry point of the nail that was taken out. It was then discovered that there was a deformation of the seal within the tube assembly. The surgeon inspected the ria to see if the seal could be replaced. The tube assembly was damaged, so the surgeon decided to use another product (canal brush) to complete the procedure. The procedure had a surgical delay of ten (10) minutes. The procedure was successfully completed. Concomitant device reported: 2. 5mm synream reaming rod (part # 352. 032s, lot # 6l09268, quantity unknown), reamer head for ria 2 (part # 03. 404. 016s lot # 38p2161, quantity unknown), unknown stryker power tool (part # unknown, lot # unknown, quantity unknown). This report is for one (1) unknown ria reamer. This is report 2 of 2 for (b)(4). (b)(4) will capture the intra-op event where the ria 2 bone harvesting kit and the unknown ria drive shaft encountered an issue during the debridement procedure, while (b)(4) will capture the post-op event where the patient underwent removal of the unknown 12mm intramedullary nail due to pain from suspected infection.

 
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Brand NameUNK - RIA
Type of DeviceREAMER
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 Key10635805
MDR Text Key210220240
Report Number8030965-2020-07741
Device Sequence Number1
Product Code HTO
Combination Product (Y/N)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/14/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/06/2020
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/19/2020
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 10/06/2020 Patient Sequence Number: 1
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