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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH PFNA-II BLADE L85 TAN ROD, FIXATION, INTRAMEDULLARY

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SYNTHES GMBH PFNA-II BLADE L85 TAN ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 04.027.052S
Device Problems Device Slipped (1584); Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/08/2021
Event Type  malfunction  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation. (b)(6). 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. 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 that on (b)(6) 2021, during a pfna ii surgery the pfna blade would not lock onto the nail. Another 85mm blade was used to complete the procedure. There was a surgical delay of fifteen (15) minutes. The procedure was completed successfully. Patient outcome was unknown. This report involves one (1) pfna-ii blade l85 tan. This is report 1 of 1 for (b)(4).
 
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Brand NamePFNA-II BLADE L85 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 Key11406302
MDR Text Key280447633
Report Number8030965-2021-01567
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 02/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.027.052S
Device Lot Number2L76591
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/10/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/07/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/20/2018
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 03/03/2021 Patient Sequence Number: 1
Treatment
UNK - NAIL HEAD ELEMENTS: PFNA-II BLADE; UNK - SCREWS: PFNA-II
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