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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - CONSTRUCTS: PFNA-II ROD, FIXATION, INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH UNK - CONSTRUCTS: PFNA-II ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number UNK - CONSTRUCTS: PFNA-II
Device Problem No Apparent Adverse Event (3189)
Patient Problems Calcium Deposits/Calcification (1758); Bone Fracture(s) (1870); Pain (1994); Non-union Bone Fracture (2369)
Event Date 06/06/2017
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). This report is for an unknown unk - constructs: pfna-ii/unknown lot number. Without the specific part number, the udi number and 510k 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 as no product was received. Investigation summary: product was not returned. Based on the information available, it has been determined that no corrective and preventive 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. (b)(4).
 
Event Description
This report is being filed after the review of the following journal article: zhang, h. Et al (2017), intertan nail versus proximal femoral nail antirotation-asia for intertrochanteric femur fractures in elderly patients with primary osteoporosis, journal of international medical research, vol. 45 (4), pages 1297-1309 (china). The aim of this retrospective comparative study is to compare the clinical and radiographic outcomes of the it and pfna-ii in the management of iffs (ao/ota type 3. 1a1. 1-a2. 3) in elderly patients with osteoporosis during a minimum 3-year follow-up period. Between january 2009 to march 2012, a total of 243 patients were included in the study. Of these, only 88 patients (34 male and 54 female) with a mean age of 74. 6±6. 3 years were treated with proximal femoral nail antirotation-asia (pfna-ii) (synthes, solothurn, switzerland) while 86 patients (30 male and 56 female) with a mean age of 72. 7±7. 6 years were treateds with a competitor's device. Follow-up assessments were performed 1, 3, 6, 9, and 12 months postoperatively and every year thereafter. Follow-up period was an average of 40 months (range, 38¿60 months). The following complications were reported as follows: 10 patients died (5 due to cerebrovascular accident, 4 due to lung cancer, and 1 due to gastric cancer). A total of 24% of patients in the pfna-ii group described some level of hip pain in the resting state, and this proportion increased to 43% in the active state. 1 patient had periprosthetic fracture. 1 patient had lateral cortex fracture. 8 patients had femoral shaft fracture after implant removal. 1 patient had delayed union. 1 patient had nonunion. 1 patient had femoral head offset. 2 patients had lower limb shortening (>1. 5 cm) 1 patient had complications of distal interlocking. 1 patient had heterotopic ossification. 6 patient had implant failure: 4 patients had screw cut-out, which cannot be adjusted or repaired, and 2 were experiencing unbearable pain due to an unstable fracture (ao/ota type 31a2. 2 and a2. 3) with medial calcar damage, without bone grafting during the operation. Revision surgery was performed as quickly as possible, without waiting for the situation to further deteriorate. 1 patient had prosthetic instability. 2 patients had screw cut-out. 1 patient had migration of proximal screw(s). This impacted product captures the following adverse events: hip pain. Periprosthetic fracture. Lateral cortex fracture. Femoral shaft fracture after implant removal. Delayed union. Nonunion. Femoral head offset. Lower limb shortening (>1. 5 cm) complications of distal interlocking. Heterotopic ossification. This report is for an unknown synthes pfna ii construct and unknown synthes screws. This report is 1 of 4 for (b)(4).
 
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Brand NameUNK - CONSTRUCTS: PFNA-II
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
eimattstrasse 3
oberdorf 4436
SZ   4436
6103142063
MDR Report Key9567059
MDR Text Key189168997
Report Number8030965-2020-00175
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeCH
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 12/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK - CONSTRUCTS: PFNA-II
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 Received12/12/2019
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: 01/08/2020 Patient Sequence Number: 1
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