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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH PFNA-II BLADE L95 TAN ROD, FIXATION, INTRAMEDULLARY

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SYNTHES GMBH PFNA-II BLADE L95 TAN ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 04.027.054S
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/10/2021
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4). Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received. The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report. 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: it was reported on that (b)(6) 2021, the patient underwent for a surgery. During the surgery, the pfna ii helical blade interlocking mechanism was failed. The locking options was failed. The surgery was successfully completed with 10-minutes delay. There were no patient consequences reported. This complaint involves one (1) device. This report is for (1) pfna-ii blade l95 tan. This report is 1 of 1 for (b)(4).
 
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Brand NamePFNA-II BLADE L95 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
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12442728
MDR Text Key270410992
Report Number8030965-2021-07577
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.027.054S
Device Lot Number164P079
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/28/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/05/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/26/2021
Is the Device Single Use? Yes
Type of Device Usage Unkown

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