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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH PFNA-II BLADE L90 TAN ROD, FIXATION, INTRAMEDULLARY

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SYNTHES GMBH PFNA-II BLADE L90 TAN ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 04.027.053S
Device Problem Migration (4003)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
Event is unknown. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Device is not distributed in the united states, but is similar to device marketed in the usa. No code is for revision surgery and injury 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) 2018, the patient underwent an unknown surgery for proximal femoral nail antirotational (pfna). The surgery was completed successfully without any surgical delay. On (b)(6) 2022, it was confirmed that cut-out occurred. The revision surgery was done on (b)(6) 2022. The pfna was removed and replaced with an artificial head. The surgeon commented that femoral neck fracture was the cause of the cut-out. It is unknown when the femoral neck fracture occurred. This is report 2 of 4 for complaint (b)(4). This report is for pfna blade.
 
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Brand NamePFNA-II BLADE L90 TAN
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key14356023
MDR Text Key291379683
Report Number8030965-2022-03121
Device Sequence Number1
Product Code HSB
UDI-Device Identifier07611819394223
UDI-Public(01)07611819394223
Combination Product (y/n)N
Reporter Country CodeJA
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
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.027.053S
Device Lot NumberL590076
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/05/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/26/2017
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 05/11/2022 Patient Sequence Number: 1
Treatment
UNK - NAIL HEAD ELEMENTS: PFNA BLADE; UNK - NAILS: PFNA
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