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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH PFNA-II Ø9 LONG LE 125° L300 TAN ROD, FIXATION, INTRAMEDULLARY

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SYNTHES GMBH PFNA-II Ø9 LONG LE 125° L300 TAN ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 473.031S
Device Problem Break (1069)
Patient Problems Pain (1994); Non-union Bone Fracture (2369)
Event Type  Injury  
Event Description
Device report from synthes reports an event in japan as follows: it was reported that on (b)(6) 2021, the patient underwent surgery for subtrochanteric fracture of femur. After surgery, in (b)(6) 2022, the distal locking screw broke but a revision surgery was not performed at that time and the patient was followed up. On (b)(6) 2022, since the patient complained pain in his/her hip joint, the surgeon checked an x-ray and confirmed that the nail was broken. A revision surgery will be performed. In the revision surgery, the nail in question will be replaced with a tfna long nail. The extracted implants are going to be discarded. Non-union was also confirmed. The surgeon assumes that poor reduction and large defects on the lateral side of the fracture resulted in non-union. This report involves one (1) pfna-ii ø9 long le 125° l300 tan. This is report 1 of 2 for (b)(4).
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803. This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date. This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report. If the information is unknown, not available or does not apply, the section/field of the form is left blank. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Therapy date: (b)(6) 2021. Pma/510k: device is not distributed in the united states, but is similar to device marketed in the usa. 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.
 
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Brand NamePFNA-II Ø9 LONG LE 125° L300 TAN
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key15234469
MDR Text Key297980984
Report Number8030965-2022-05800
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,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 Received08/16/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number473.031S
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/19/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 08/16/2022 Patient Sequence Number: 1
Treatment
UNK - NAIL HEAD ELEMENTS: PFNA BLADE; UNK - SCREWS: NAIL DISTAL LOCKING
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