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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH TFNA HELICAL BLADE PERF L85 TAN SPIRAL BLADE

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SYNTHES GMBH TFNA HELICAL BLADE PERF L85 TAN SPIRAL BLADE Back to Search Results
Catalog Number 04.038.385S
Device Problem Migration (4003)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 03/18/2022
Event Type  Injury  
Manufacturer Narrative
Reporter is a j&j sales representative. The investigation could not be completed; no conclusion could be drawn, as no product was received. Investigation summary product was not returned. Based on the information available, it has been determined that no corrective and 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 a manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified. 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 depuy synthes reports an event in (b)(6) as follows: this is report 2 of 2 for (b)(4). It was reported that postoperatively to an open reduction internal fixation procedure with the tfna device for the fracture of the trochanteric femur, a cut-out occurred on (b)(6) 2022. According to the report, the initial surgery was completed successfully without any surgical delay. It was further reported that the implants will be removed on (b)(6) 2022. The total hip arthroplasty and the bipolar hip arthroplasty will not be performed. The status of the patient was unknown. No additional information was provided.
 
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Brand NameTFNA HELICAL BLADE PERF L85 TAN
Type of DeviceSPIRAL BLADE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key14120667
MDR Text Key289358877
Report Number8030965-2022-02472
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K160167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/15/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.038.385S
Device Lot Number356P182
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/17/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/01/2021
Is the Device Single Use? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/15/2022 Patient Sequence Number: 1
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