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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 Problem Pulmonary Embolism (1498)
Event Type  Death  
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. 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: ergin ¿. N. , et al (2020)prognostic factors affecting survival of patients with intertrochanteric femoral fractures over 90 years treated with proximal femoral nailing, european journal of trauma and emergency surgery volume 46, pages 663669 (b)(6) this retrospective study aims to identify the prognostic factors that influence survival results of patients with intertrochanteric fractures aged >90 years treated with intramedullary nailing. Between january 2009 and december 2018, records of 53 patients (39 females, 14 males) average age was 92. 8 ¿ 2. 7 (range90103) years operated for intertrochanteric femur fractures were reviewed. In all patients, either pfna¿ ((synthes, oberdorf, switzerland) or intertan¿ (smith & nephew, memphis, tn) was used. Thirty-five patients were operated with pfna and eighteen patients with inter-tan. After discharge, patients were followed at the outpatient clinic at 1, 2, 6 and 12 weeks, at 6 months and thereafter once a year or until death. The following complications were reported as follows: at the time of this study, 32 patients had deceased. Mortality: in first month (n) 5, in first year (n) 7. One patient died due to massive pulmonary embolism 2 days after the surgery. The failure rate was 9. 4% (n: 5) and three patients underwent revision surgery. One patient had massive pulmonary embolism 2 days after the surgery. (deceased). This report is for an unknown synthes pfna¿. A copy of the literature article is being submitted with this medwatch. This report is for (1) unk - constructs: pfna. This is report 2 of 2 (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 wright lane east
west chester, PA 19380
6107195000
MDR Report Key11368201
MDR Text Key233239777
Report Number8030965-2021-01280
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeTU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
Type of Report Initial
Report Date 02/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2021
Is this an Adverse Event Report? No
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 Received02/02/2021
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: 02/23/2021 Patient Sequence Number: 1
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