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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - END CAPS: AFN ROD, FIXATION, INTRAMEDULLARY

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SYNTHES GMBH UNK - END CAPS: AFN ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Necrosis (1971)
Event Date 12/06/2021
Event Type  Injury  
Manufacturer Narrative
This report is for an unk - end caps: afn/unknown lot. Part and lot number are unknown. Without the specific part number; the udi number and 510-k 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. 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) 2021, antegrade femoral nail(afn) was removed successfully. Initial surgery of insertion was 2015 and the fracture had healed, however was required to be removed due to avascular necrosis of hip. No patient consequences. This report is for one (1) unk - end caps: afn. This is report 5 of 6 for complaint (b)(4).
 
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Brand NameUNK - END CAPS: AFN
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 Key13122201
MDR Text Key285762991
Report Number8030965-2021-10588
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2021
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
Date Manufacturer Received12/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/30/2021 Patient Sequence Number: 1
Treatment
AFN Ø13 LE L360 TAN; UNK - NAIL HEAD ELEMENTS: HIP SCREW; UNK - NAIL HEAD ELEMENTS: HIP SCREW; UNK - SCREWS: TRAUMA; UNK - WASHERS
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