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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - NAILS: PFNA ROD, FIXATION, INTRAMEDULLARY

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SYNTHES GMBH UNK - NAILS: PFNA 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
This report is for an unknown nails: pfna/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. 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: this report is being filed after the review of the following journal article: mingo-robinet j, et al. (2021), fluoroscopic landmarks to recognize iatrogenic varus displacement (wedge effect) during cephalomedullary nailing of intertrochanteric fractures, injury, pages 1-7 (spain) the purpose of the current study is to determine the incidence of the ¿¿wedge effect¿¿ associated with usage of the intramedullary nailing for intertrochanteric femur fractures in our population and to define easy fluoroscopic landmarks to identify and prevent the wedge effect. Between january 2017 and july 2019, there were 369 extracapsular hip fractures operated in which 55 fractures with a varus malreduction were found on postoperative x-rays. Of these, 35 patients with intraoperative fluoroscopic images recorded were included in the study. A total of 31 were female, and the overall mean age was 86. 6 (range 70-97) years. The included patients had residual varus malreduction of the hip operated in postoperative pelvis radiographs and with at least 1 anteroposterior and 1 axial intraoperative fluoroscopy images recorded to assess that perfect reduction in anteroposterior and axial views was obtained with close reduction at the very beginning of the procedure, and posteriorly, an iatrogenic varus malreduction was produced when inserting the nail (wedge effect). 15 of these patients were treated with the unknown synthes 130 degrees proximal femoral nail antirotation, 8 with unknown synthes 125 degrees proximal femoral nail antirotation while the rest of the patients were treated with a competitor¿s device. Complications were reported as follows: a total of 55 fractures with a varus malreduction were found on postoperative x-rays. 4 patients died in the first 3 months after surgery. Case 2, a (b)(6) year-old male implanted with pfna 130 degrees had an iatrogenic varus malreduction that was produced when inserting the nail. Case 4, an (b)(6) year-old female implanted with pfna 130 degrees had an iatrogenic varus malreduction that was produced when inserting the nail. Case 5, an (b)(6) year-old female implanted with pfna 125 degrees had an iatrogenic varus malreduction that was produced when inserting the nail. Case 6, a (b)(6) year-old female implanted with pfna 130 degrees had an iatrogenic varus malreduction that was produced when inserting the nail. Case 8, a (b)(6) year-old female implanted with pfna 130 degrees had an iatrogenic varus malreduction that was produced when inserting the nail. This patient died in the early postoperative period. Case 11, an (b)(6) year-old female implanted with pfna 130 degrees had an iatrogenic varus malreduction that was produced when inserting the nail. Case 12, an (b)(6) year-old male implanted with pfna 130 degrees had an iatrogenic varus malreduction that was produced when inserting the nail. This patient died in the early postoperative period. Case 13, a (b)(6) year-old female implanted with pfna 130 degrees had an iatrogenic varus malreduction that was produced when inserting the nail. Case 18, a (b)(6) year-old female implanted with pfna 130 degrees had an iatrogenic varus malreduction that was produced when inserting the nail. Case 19, a (b)(6) year-old female implanted with pfna 125 degrees had an iatrogenic varus malreduction that was produced when inserting the nail. Case 20, a (b)(6) year-old female implanted with pfna 130 degrees had an iatrogenic varus malreduction that was produced when inserting the nail. Case 22, a (b)(6) year-old male implanted with pfna 125 degrees had an iatrogenic varus malreduction that was produced when inserting the nail. Case 23, an (b)(6) year-old female implanted with pfna 125 degrees had an iatrogenic varus malreduction that was produced when inserting the nail. Case 24, a (b)(6) year-old female implanted with pfna 130 degrees had an iatrogenic varus malreduction that was produced when inserting the nail. Case 25, a (b)(6) year-old female implanted with pfna 130 degrees had an iatrogenic varus malreduction that was produced when inserting the nail. Case 26, an (b)(6) year-old female implanted with pfna 125 degrees had an iatrogenic varus malreduction that was produced when inserting the nail. Case 28, an (b)(6) year-old female implanted with pfna 125 degrees had an iatrogenic varus malreduction that was produced when inserting the nail. Case 30, a (b)(6) year-old female implanted with pfna 130 degrees had an iatrogenic varus malreduction that was produced when inserting the nail. Case 31, an (b)(6) year-old female implanted with pfna 130 degrees had an iatrogenic varus malreduction that was produced when inserting the nail. Case 32, an (b)(6) year-old female implanted with pfna 130 degrees had an iatrogenic varus malreduction that was produced when inserting the nail. Case 33, a (b)(6) year-old female implanted with pfna 125 degrees had an iatrogenic varus malreduction that was produced when inserting the nail. Case 34, a (b)(6) year-old female implanted with pfna 125 degrees had an iatrogenic varus malreduction that was produced when inserting the nail. Case 35, a (b)(6) year-old female implanted with pfna 130 degrees had an iatrogenic varus malreduction that was produced when inserting the nail. This report is for the unknown synthes 130 degrees proximal femoral nail antirotation nail and unknown synthes 125 degrees proximal femoral nail antirotation nail. A copy of the literature article is being submitted with this medwatch. This is report 5 of 17 for (b)(4).
 
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Brand NameUNK - NAILS: PFNA
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 Key12129658
MDR Text Key271086584
Report Number8030965-2021-05587
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeSP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 06/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2021
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 Received06/24/2021
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: 07/07/2021 Patient Sequence Number: 1
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