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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - NAIL HEAD ELEMENTS: PFNA-II BLADE ROD, FIXATION, INTRAMEDULLARY

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SYNTHES GMBH UNK - NAIL HEAD ELEMENTS: PFNA-II BLADE ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problem Migration (4003)
Patient Problems Pain (1994); Discomfort (2330)
Event Type  Injury  
Manufacturer Narrative
This report is for an unk - nail head elements: pfna-ii blade/unknown lot. Part and lot numbers are unknown; udi 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 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, no further action is required at this time. Complaint information is trended on a regular basis to determine if further investigation is warranted. 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 korea, south as follows: this report is being filed after the review of the following journal article: oh j-k, hwang j-h, sahu d (2010), nailing of intertrochanteric fractures: review on pitfalls and technical tips, journal of orthopedics, trauma and rehabilitation, volume 14, pages 3-7 (south korea). In this study, the authors describe the advantages and drawbacks of nailing over the dynamic hip screw for the fixation of hip fractures. The technical pitfalls of nailing and the tips to avoid failure of fixation in nailing have been discussed. Between march 1, 2007 and february 28, 2009, 101 intertrochanteric fractures with the unknown synthes proximal femoral nail anti-rotation were performed. There were who 6 patients died from other causes after discharge from the hospital while 7 patients were lost to follow-up. A total of 88 patients were followed up more than 6 months or to the point when fracture healing has occurred. Complications were reported: 1 patient had irritation and pain over the blade due to excessive sliding. The patient underwent revision surgery with the blade changed with a shorter one and the fracture healed uneventfully. 1 patient had femoral head perforation due to migration of the blade just like the z-effect. The patient underwent revision surgery with the blade changed with a shorter one and the fracture healed uneventfully. Unknown patients had incidence of postoperative lateral wall fracture of a1 and a2 fractures. This report is for the unknown synthes proximal femoral nail anti-rotation. This report is for (1) unk - nail head elements: pfna-ii blade. This report is 3 of 3 for (b)(4).
 
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Brand NameUNK - NAIL HEAD ELEMENTS: PFNA-II BLADE
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 Key12344348
MDR Text Key268219774
Report Number8030965-2021-06900
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeKS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
Type of Report Initial
Report Date 07/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/19/2021
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 Received07/21/2021
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: 08/19/2021 Patient Sequence Number: 1
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