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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 Bone Fracture(s) (1870); Necrosis (1971); Non-union Bone Fracture (2369); Post Operative Wound Infection (2446)
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). This report is for an unk - 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 as no product was received. The investigation could not be completed, no conclusion could be drawn at the time of filing this report. The product was not returned. Based on the information available, it has been determined that no corrective and 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: yamamoto n. , et al (2021) reduction quality and nail fixation ratio as bone-implant stability factors associated with reoperation for trochanteric fractures, injury xxx (xxxx) xxx , pages 1-6 (japan). This retrospective study aims to evaluate the association between bone- implant stability factors, including the imn construct, and post-operative outcomes, especially reoperation, in a more extensive case series and with comprehensive variables. Between january 2008 and june 2020, 390 consecutive patients (306 females, 84 males) with a mean age of 82. 9 ¿8. 3 years at the time of surgery who underwent imn for an acute trochanteric fracture ao/ota 31a1, a2, and a3 types at a (b)(6) were included in the study. During the fixation nails used included proximal femoral nail antirotation (pfna), japanese pfna (depuy synthes, warsaw, in, usa), and other competitors devices. The implant type and size were selected according to the surgeons preference. Patients were followed up at least three months postoperatively. The following complications were reported: 1 reoperation due to non-union (short nail group). 1 reoperation due to secondary femoral fracture due to falling (short nail group). 1 reoperation due to osteonecrosis (short nail group). 1 reoperation due to infection (short nail group). 1 reoperation due to iatrogenic surgical error (short nail group). 37 intraoperative femoral fracture (short nail group). 1 secondary femoral fracture (short nail group). 68 complication grades (2
=
) (short nail group). 1 reoperation due to nonunion (long nail group). 8 intraoperative femoral fracture (long nail group). 18 complication grades (2
=
) (long nail group). Blood loss volume, cc (sd) 255. 80 (208. 835) (long nail group). 4 re-operation due to cut out (short nail group). 1 reoperation due to cut-out (long nail group). 1 reoperation due to blade perforation (short nail group). 1 reoperation due to implant breakage (short nail group). This report is for an unknown synthes proximal femoral nail antirotation (pfna) and japanese pfna. This report is for (1) unk - constructs: pfna. This report is 3 of 12 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 Key12169817
MDR Text Key273319243
Report Number8030965-2021-05742
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2021
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 Received08/20/2021
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: 07/14/2021 Patient Sequence Number: 1
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