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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: TFNA ROD, FIXATION, INTRAMEDULLARY

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SYNTHES GMBH UNK - CONSTRUCTS: TFNA ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Physical Asymmetry (4573)
Event Type  Injury  
Manufacturer Narrative
Additional narrative: 510k: this report is for an unknown tfna constructs/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
This report is being filed after the review of the following journal article: nayar, s. K. Et al. (2021), implant fracture of the tfna femoral nail, journal of clinical orthopaedics and trauma, vol. 22, pages 1-6 (united kingdom) the aim of this study was to evaluate all tfna implant fractures at a uk trauma unit to ascertain any patient or surgical factors associated with implant failure. From june 2017 to december 31, 2020, a total of 127 fixations using the tfna for proximal femur fractures were performed. The mean age at the time of index surgery was 72. 1 years. The following complications were reported as follows: 6 cases of implant fracture at the aperture for the proximal screw occurred, of which two occurred in the same patient. All six cases displayed radiographic nonunion at the time of implant fracture. All cases underwent revision surgery. 1 case was revised to a six-hole dynamic hip screw (depuy synthes). 1 case was revised to a cemented hemiarthroplasty (excia® hip stem system, bbraun). 1 case was revised to an uncemented total hip replacement (bicontact® hip stem system, bbraun). 2 cases were exchanged to further tfna nails. This occurred in the same patient, where an initial broken tfna was exchanged for a further tfna, this subsequently broke thus necessitating the proximal femoral replacement. 1 case underwent a proximal femoral replacement at a tertiary referral unit. Reduction quality was considered good in two cases, acceptable in two cases and poor in the remaining two. This report is for an unknown synthes tfna construct. It captures the reported event of reduction quality was poor in 2 cases. A copy of the literature article is being submitted with this medwatch. This is report 4 of 9 for (b)(4).
 
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Brand NameUNK - CONSTRUCTS: TFNA
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
MDR Report Key12739227
MDR Text Key279673515
Report Number8030965-2021-09210
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial
Report Date 10/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/10/2021
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: 11/02/2021 Patient Sequence Number: 1
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