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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH BOLT Ø4.9 SELF-TAP L34 TAV GREEN ROD, FIXATION, INTRAMEDULLARY

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SYNTHES GMBH BOLT Ø4.9 SELF-TAP L34 TAV GREEN ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 459.340VS
Device Problem Migration (4003)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
Date of event: 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. 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 antirotation (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 4 of 4 for complaint (b)(4). This report is for pfna bolt.
 
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Brand NameBOLT Ø4.9 SELF-TAP L34 TAV GREEN
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 Key14356806
MDR Text Key291385939
Report Number8030965-2022-03127
Device Sequence Number1
Product Code HSB
UDI-Device Identifier07611819702523
UDI-Public(01)07611819702523
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
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 Number459.340VS
Device Lot Number5943787
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/30/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/05/2017
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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