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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH PFNA BLADE PERF L90 TAN NAIL, FIXATION, INTRAMEDULLARY

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SYNTHES GMBH PFNA BLADE PERF L90 TAN NAIL, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 04.027.033S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Non-union Bone Fracture (2369)
Event Type  Injury  
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803. This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date. This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report. If the information is unknown, not available or does not apply, the section/field of the form is left blank. H10 additional narrative: postal code (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 on (b)(6) 2022, that pfna revision after patient had fallen on the same injured leg 1. 5 years ago. Initial pfna implantation was 1. 5 years ago at st vincent¿s public hospital. Exact date and surgeon unknown. Fracture went to nonunion and was also fixated with supercables x2. Pfna removed successfully and revised with new pfna nail. There was no patient outcome/consequences. Concomitant device reported: unk - screws: nail distal locking (part# unknown; lot# unknown; quantity# unknown) this report is for one (1) pfna blade perf l90 tan this is report 1 of 2 for complaint (b)(4).
 
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Brand NamePFNA BLADE PERF L90 TAN
Type of DeviceNAIL, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK BETTLACH (CH)
muracherstrasse 3
bettlach
Manufacturer Contact
kate karberg
eimattstrasse 3
oberdorf 
SZ  
6103142063
MDR Report Key15254676
MDR Text Key298197645
Report Number8030965-2022-05861
Device Sequence Number1
Product Code HSB
UDI-Device Identifier07611819368972
UDI-Public(01)07611819368972
Combination Product (y/n)N
Reporter Country CodeAS
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
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number04.027.033S
Device Lot Number74P4335
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/08/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/03/2020
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 08/18/2022 Patient Sequence Number: 1
Treatment
UNK - SCREWS: NAIL DISTAL LOCKING
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