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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH PFNA-II Ø10 130° L240 TAN ROD, FIXATION, INTRAMEDULLARY

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SYNTHES GMBH PFNA-II Ø10 130° L240 TAN ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 473.805S
Device Problem Material Deformation (2976)
Patient Problems Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 03/07/2022
Event Type  Injury  
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that a device deformed post-op. This case is from health authority. It was reported that the patient was hospitalized with femoral fracture, and then underwent operation. The intramedullary device was implanted during the operation. Recently, he was hospitalized due to the problem of internal fixation device. After film examination, it was found that the device intramedullary was bent and could not achieve the effect of support. The patient underwent secondary surgery. No additional information can be provided. This complaint involves one (1) device pfna-ii ø10 130° l240 tan. This is report 1 of 1 for complaint (b)(4).
 
Manufacturer Narrative
Product complaint # (b)(4). 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. (b)(4). A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified. 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.
 
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Brand NamePFNA-II Ø10 130° L240 TAN
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK BETTLACH (CH)
muracherstrasse 3
bettlach 2544
SZ 2544
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key14134670
MDR Text Key289427234
Report Number8030965-2022-02485
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number473.805S
Device Lot Number4L10277
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/06/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/11/2019
Is the Device Single Use? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/18/2022 Patient Sequence Number: 1
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