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U.S. Department of Health and Human Services

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

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SYNTHES GMBH UNK - NAIL HEAD ELEMENTS: PFNA BLADE ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problem Migration (4003)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown helical blade/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. (b)(4). 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
This report is being filed after the review of the following journal article: brunner, a. Et al. (2016), what is the optimal salvage procedure for cut-out after surgical fixation of trochanteric fractures with the pfna or tfn? a multicentre study, injury, vol. 47, pages 432-438 (austria). The purpose of the study was to evaluate the failure and success rates of salvage procedures for cutting-out and cutting-through of blades and to offer data-based recommendations on the optimal treatment strategy for each type of complication. Between 2003 and 2010, 57 patients underwent nailing of trochanteric fractures using pfna or tfn. These patients were divided into 2 groups. The cut-through group had 28 patients (22 females and 6 males) with a mean age of 77. 8 years. The cut-out group had 29 patients (24 females and 5 males) with a mean age of 83. 3 years. The following complications were reported as follows: 1 patient died after a follow-up period of 5. 7 months for medical reasons unrelated to implant failure. 21 patients had moderate reductions and 26 cases had poor reductions. 28 patients had a cut-through of the helical blade (3 for tfn and 25 for pfna). All these patients had revision surgery. 29 patients had a cut-out of the helical blade (7 for tfn and 22 for pfna). Patients underwent metal removal and re-nailing of the fracture with a new pfna. One of these fractures healed. One patient developed re-perforation of the blade and required a second revision procedure with tha. One patient sustained a deep wound infection after re-nailing and required two more revision operations. Finally, the patient had a cement spacer inserted, which became the definite treatment this report is for an unknown synthes pfna helical blade. This report captures the reported cut-through of the helical blade and revision surgery. This is report 2 of 20 for (b)(4). Additional devices are reported under related complaints (b)(4).
 
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Brand NameUNK - NAIL HEAD ELEMENTS: PFNA BLADE
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key12345576
MDR Text Key267898530
Report Number8030965-2021-06931
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeAU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
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? Yes
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 Received10/05/2021
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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