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U.S. Department of Health and Human Services

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

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SYNTHES GMBH UNK - CONSTRUCTS: PFNA-II ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bone Fracture(s) (1870)
Event Type  Injury  
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803. This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date. This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report. If the information is unknown, not available or does not apply, the section/field of the form is left blank. This report is for an unknown pfna constructe/unknown lot. Part and lot numbers are unknown; udi number is unknown. Device avilable for evaluation: complainant part is not expected to be returned for manufacturer review/investigation. Reporter telephone number: (b)(6). Device evaluated by mfr and manufacture date: 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: kim, y. V. Et al (2022), impact of coronal plane fragments and anterior big neck fragments on the occurrence of perioperative lateral wall fractures in ao/ota 31-a1,2 intertrochanteric fractures treated with cephalomedullary nailing, european journal of trauma and emergency surgery, vol xx (xx), pages 1-7 (korea, south). The aim of this retrospective study was to find the association between the type of coronal fragments and perioperative lateral wall fractures during treatment of pertrochanteric fractures with cmns. Between september 2016 to december 2020, a total of 463 patients (136 male and 326 female) with a mean age of 80. 1 years (31¿100) were included. The cephalomedullary nails used were pfna (pfnaii, synthes, paoli, pa, usa) or gamma nails (stryker, mahwah, nj, usa). Provisional pins, which keep the fracture reduction intact during proximal reaming and nail insertion, were used by the surgeon's discretion. Postoperative radiographs were obtained the day after surgery. Follow up radiographs were taken one week later, two weeks later, one month later, three months later, and so on. Perioperative fracture of the lateral wall was confirmed by the presence of fracture line at the blade entry site on both anteroposterior and lateral radiographs (fig. 3). The following complications were reported as follows: 22 patients had perioperative lateral wall fractures (implant used in 21 were pfna and 1 with a competitor). Patients treated with pfna were as follows: a 90-year-old female patient, an 82-year-old female patient, an 82-year-old male patient, an 83-year-old female patient, a 90-year-old female patient, an 83-year-old male patient, an 89-year-old male patient, a 91-year-old female patient, a 75-year-old female patient, a 77-year-old male patient, a 73-year-old male patient, an 88-year-old female patient, an 87-year-old female patient, an 81-year-old female patient, an 89-year-old female patient, a 100-year-old female patient, an 82-year-old female patient, a 92-year-old male patient, a 79-year-old female patient, a 68-year-old male patient, an 88-year-old female patient. This is report 11 of 20 for (b)(4). This report is for an unknown synthes pfna ii. (75 year old female patient) this complaint is linked to (b)(4).
 
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Brand NameUNK - CONSTRUCTS: PFNA-II
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key15113227
MDR Text Key296688957
Report Number8030965-2022-05268
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeKS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2022
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
Date Manufacturer Received06/28/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 07/27/2022 Patient Sequence Number: 1
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