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U.S. Department of Health and Human Services

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

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SYNTHES GMBH UNK - CONSTRUCTS: PFNA ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bone Fracture(s) (1870); Unspecified Tissue Injury (4559)
Event Type  Injury  
Manufacturer Narrative
510k: this report is for an unknown nail/unknown lot. Part and lot numbers are unknown; udi number is unknown. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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: kruse m. , et al (2021) peri-implant femoral fractures in hip fracture patients treated with osteosynthesis: a retrospective cohort study of 1965 patients, european journal of trauma and emergency surgery volume xxxx, pages 1-6 (sweden). This retrospective cohort study aims to investigate the incidence of postoperative peri-implant femoral fractures (piff) following osteosynthesis of proximal femoral fractures. Between 2003 and 2015, 1965 patients (685 males, 1280 females) mean age 80 years [range 50¿102]) with trochanteric hip fractures with osteosynthesis were included. Of these, 382 ( were treated with a cmn, 933 with shd and 650 with pins for femoral neck fractures. The following devices were used either a long or short cmn (gamma3® (stryker, kalamazoo, mi, usa), pfn/pfna (depuy synthes®)), shd (dynamic hip screw (dhs, depuy synthes®) or hansson twin-hook (swemac orthopaedics ab, linköping, sweden)) based on surgeons´ preference. Femoral neck fractures (fnf) were treated with pins (hansson hook pin system (swemac orthopaedics ab, linköping, sweden). Patients were followed-up until removal or for a mean of 4 years (range 0¿15) replacement of osteosynthesis, death or december 2018. The following complications were reported as follows: the 1-year mortality in the entire cohort was 23%. The 1-year mortality rate after piff was 34%. A total of 41 piffs were identified at a mean time of 27 months (range 0¿143 months) postoperatively. In total 27 of 41 patients underwent surgery for piff and 4 (4/27) needed revision surgery. The cumulative incidence of piff was 0. 8% for cmn, 2. 7% for shd (hr 2. 9, 95% ci 0. 87¿9. 6, p
=
0. 08) and 2. 0% (hr 2. 3, 95% ci 0. 6¿8. 1, p
=
0. 2) for pins using the cmn as the denominator. Among cmn, 2 piffs occurred with short cmn (n
=
250) and 1 piff with a long cmn (n
=
132) 1 posttraumatic osteoarthritis-arthroplasty. 1 wound rupture. 1 cmn: cut-out reosteosynthesis. This report is for an unknown synthes pfn/pfna nail. This is report 2 of 5 for (b)(4).
 
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Brand NameUNK - CONSTRUCTS: PFNA
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key12343090
MDR Text Key267435668
Report Number8030965-2021-06866
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeSW
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 07/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/19/2021
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 Received09/21/2021
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: 08/19/2021 Patient Sequence Number: 1
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