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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH ROD,FIXATION,INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Device Problem Failure to Align (2522)
Patient Problem No Code Available (3191)
Event Date 01/01/2019
Event Type  Injury  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation. (b)(4). 510k: this report is for an unknown guides/sleeves/aiming: aiming arm/unknown lot. Part and lot number are unknown; udi number is unknown. 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.
 
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the patient underwent an unknown procedure using an expert a2fn cannulated nail. During the operation, the surgeon used an unknown old reamer set to ream with an 11. 5mm diameter, however, the nail was difficult to insert into the femoral bone and had to withdraw it and replaced with a new reamer set. Unfortunately, the proximal part of the nail that connected to the jig has been bent during insertion and decided to withdraw the procedure that led to an inaccuracy of an unknown drill bit to pass through the proximal hole. Thus, the surgeon had to change with another nail to complete the procedure. The procedure was successfully completed with four (4) hours surgical delay and the patient had to undergo prolonged anesthesia. There was no patient harm reported. Concomitant medical products reported: unknown drill bit (part# unknown, lot# unknown, quantity 1); unknown reamer set (part# unknown, lot# unknown, quantity 1); unknown jig (part# unknown, lot# unknown, quantity 1). This complaint involves five (5) device. This report is 5 of 5 for (b)(4).
 
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Type of DeviceROD,FIXATION,INTRAMEDULLARY
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 Key8484438
MDR Text Key140958976
Report Number8030965-2019-62507
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeMY
Number of Events Reported1
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 03/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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 Received03/11/2019
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?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/04/2019 Patient Sequence Number: 1
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