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U.S. Department of Health and Human Services

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

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SYNTHES GMBH UNK - CONSTRUCTS: PFNA LONG ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Ossification (1428); Bone Fracture(s) (1870); Non-union Bone Fracture (2369); Post Operative Wound Infection (2446)
Event Type  Injury  
Manufacturer Narrative
Pma/510k: this report is for an unknown constructs: 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: rai, s. Et al. (2020), do various lengths of proximal femoral nail have any effect on fracture union in a trochanteric fracture in elderly?, journal of musculoskeletal research, vol. 23, no. 4, page 1-13 (india). This study aimed to find out whether various length of pfn plays any role in union of trochanteric fracture in elderly. Between march 2010 and december 2017, a total of 503 patients (369 males and 134 females were treated with a pfna. 242 patients had a long pfna while 261 patients had a short pfna. The mean age for the long pfna group was 80. 5 years (range: 65¿96 years) and 79. 5 years (range: 65¿94 years) for the short pfna group. All patients were kept under follow up at 1, 6, 9 and 12 months after the surgery. The following complications were reported as follows: 6 patients died after 14 months post surgery and all were more than 85 year of age. 2 patients developed superficial infection and were managed by appropriate antibiotics 2 patients developed peri-implant fracture after 9 months of index surgery was treated by plating and wiring. 11 patients had nonunion and were treated by autologous bone grafting. 21 patients had immediate post operative infection which was treated by appropriate antibiotics-all recovered. 9 patients had delayed infection which was treated by wound exploration, debridement and appropriate antibiotics-recovered. 3 patients had heterotrophic ossification. 46 patients had a fair score for their hip evaluation. 5 patients had a poor score for their hip evaluation. 3 patients had loosening of implants and were managed by exchange nail with greater diameter nail. 2 patients had neck screw backout and were treated by hemireplacement cemented arthroplasty. 3 patients had neck screw cutout and were treated by hemireplacement cemented arthroplasty. 4 patients had screw migration which was treated by replacement of neck screw. This report is for an unknown synthes pfna. This is report 1 of 5 for (b)(4).
 
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Brand NameUNK - CONSTRUCTS: PFNA LONG
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 Key12256407
MDR Text Key266855447
Report Number8030965-2021-06289
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeIN
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 07/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/30/2021
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 Received07/02/2021
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: 07/30/2021 Patient Sequence Number: 1
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