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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH PFNA BLADE PERF L110 TAN ROD, FIXATION, INTRAMEDULLARY

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SYNTHES GMBH PFNA BLADE PERF L110 TAN ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 04.027.037S
Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Death (1802); Hematoma (1884); No Code Available (3191)
Event Date 01/01/2020
Event Type  Death  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation. Device is not distributed in the united states, but is similar to device marketed in the usa. 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. (b)(4). 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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2020 the patient was implanted with a hip prosthesis. On (b)(6) 2020 the patient underwent a removal operation of two (2) screws (1 cephalic screw and 1 distal screw) and the nail had been retrieved with repose of device due to a hematoma and abscess. The proximal femoral nail antirotation (pfna) blade was completely disunited. The surgeon retrieved four (4) separated parts from the patient. There was a surgical delay of less than 30 minutes. The patient died on (b)(6) 2020 of a probable septic shock. This report is for one (1) pfna blade. This is report 1 of 5 for (b)(4).
 
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Brand NamePFNA BLADE PERF L110 TAN
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
orberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK BETTLACH (CH)
muracherstrasse 3
bettlach 2544
SZ 2544
Manufacturer Contact
kara ditty-bovard
eimattstrasse 3
orberdorf, PA 4436
SZ   4436
6107195000
MDR Report Key10601157
MDR Text Key209021095
Report Number8030965-2020-07511
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 09/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.027.037S
Device Lot Number62P6170
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/01/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/03/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/27/2020
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: 09/29/2020 Patient Sequence Number: 1
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