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Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bone Fracture(s) (1870); Hematoma (1884); Pain (1994); Discomfort (2330)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown pfna construct/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: seyhan m, et al. (2015), do pfna devices and intertan nails both have the same effects in the treatment of trochanteric fractures? a prospective clinical study, j orthop sci, volume 20, pages 1053¿1061 (turkey). The objective of this study is to clinically and radiologically compare third generation intramedullary nails used in the treatment of trochanteric hip fractures and to determine their efficacy. 75 patients with a diagnosis of trochanteric fracture in the last 6 years with a minimum follow-up period of 1 year were included in the study; 43 were treated with the unknown synthes pfna proximal femoral nail antirotation devices and 32 with a competitor¿s intertan nails. The patients treated with pfna devices consisted of 32 females and 11 males with a mean age of 75. 91 +/-13. 77 years. Isometric quadriceps and active ankle dorsiflexion plantar flexion exercises were begun immediately after surgery. Mechanical calf pumps were used for uncooperative patients. Patients were advised to use walkers with touch-down weight bearing, but those who failed to achieve this task proceeded with weight bearing as tolerated. At the 1-month follow-up evaluation, walkers were replaced by canadian crutches for use in the contralateral hand in patients who could tolerate this exchange. Patients were told to stop using the crutch whenever they felt they no longer needed it. The mean follow-up period was 19. 4 (range 12¿60) months. Complications were reported as follows: 2 patients had hematomas developed in the lateral thigh region. 1 patient had persistent thigh pain after 1 year, which was resolved by analgesics and physical therapy. 1 patient had a fracture in the lateral cortex. The fracture healed without requiring additional treatment and did not affect the patient¿s time to mobilization. 5 patients had implant-related discomfort even after fracture union. None of these patients required implant removal. 1 patient treated with a 24-cm pfna device had the distal end of the nail cause a nondisplaced fracture in the anterior cortex. Because the fracture was stable, no additional surgical procedure was carried out, and the patient was given a brace to be used while walking. This complication did not postpone the time to full weight bearing. This report is for the unknown synthes proximal femoral nail antirotation (pfna) construct. This report captures the reported hematomas, persistent thigh pain, implant related discomfort and fracture in the lateral cortex. This is report 2 of 2 for (b)(4).
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Manufacturer (Section D)
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
MDR Report Key12267434
MDR Text Key264805000
Report Number8030965-2021-06360
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeTU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/03/2021
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 Received08/04/2021
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: 08/03/2021 Patient Sequence Number: 1