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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - SCREWS: TRAUMA; SCREW, FIXATION, BONE

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SYNTHES GMBH UNK - SCREWS: TRAUMA; SCREW, FIXATION, BONE 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
If the information is unknown, not available or does not apply, the section/field of the form is left blank.This report is for an unk - screws: trauma/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 - screws: trauma.This is report 4 of 6 for complaint (b)(4).
 
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Brand Name
UNK - SCREWS: TRAUMA
Type of Device
SCREW, FIXATION, BONE
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 Key13122209
MDR Text Key286016075
Report Number8030965-2021-10589
Device Sequence Number1
Product Code HWC
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
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
Initial Date Manufacturer Received 12/05/2021
Initial Date FDA Received12/30/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
AFN Ø13 LE L360 TAN; UNK - END CAPS: AFN; UNK - NAIL HEAD ELEMENTS: HIP SCREW; UNK - NAIL HEAD ELEMENTS: HIP SCREW; UNK - WASHERS
Patient Outcome(s) Required Intervention;
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