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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - NAILS: RAFN ROD, FIXATION, INTRAMEDULLARY

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SYNTHES GMBH UNK - NAILS: RAFN ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Non-union Bone Fracture (2369); Embolism/Embolus (4438)
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). This report is for an unk - nails: rafn/unknown lot. Part and lot numbers are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/ investigation. Reporter is a j&j representative. Without a lot number, the device history records review could not be completed as no product was received. The investigation could not be completed, no conclusion could be drawn at the time of filing this report. The product was not returned. Based on the information available, it has been determined that no corrective and 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.
 
Event Description
It was reported that on an unknown date, the patient underwent an unknown procedure with antegrade approach for a poly trauma at femoral shaft. Postoperatively, there was no union of fracture noted and patient was already back to work and patient had an initial confusion at post op from the supported fat embolism syndrome. There was an evidence of healing reported. No further information is available. Concomitant devices reported: unknown nail head elements: rafn spiral blade (part# unknown, lot# unknown, quantity 1); unknown end caps: rafn (part# unknown, lot# unknown, quantity 1); unknown screws: nail distal locking (part# unknown, lot# unknown, quantity 1); this complaint involves four (4) devices. This report is for (1) unk - nails: rafn. This report is 1 of 4 for (b)(4).
 
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Brand NameUNK - NAILS: RAFN
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12189379
MDR Text Key262243807
Report Number8030965-2021-05876
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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 Received10/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 07/19/2021 Patient Sequence Number: 1
Treatment
UNK - END CAPS: RAFN; UNK - NAIL HEAD ELEMENTS: RAFN SPIRAL BLADE; UNK - SCREWS: NAIL DISTAL LOCKING
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