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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH TFNA HELICAL BLADE L85 TAN ROD,FIXATION,INTRAMEDULLARY

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SYNTHES GMBH TFNA HELICAL BLADE L85 TAN ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 04.038.285S
Device Problem Migration (4003)
Patient Problem Pain (1994)
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Complainant part is not expected to be returned for manufacturer review/investigation. Reporter is a j&j representative. The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report. 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) 2020, the patient underwent the surgery for the trochanteric femur fracture with tfna system in question. The surgery was completed successfully without any surgical delay. On an unknown date, the patient felt pain when walking recently and visited the hospital. It was confirmed that the upper half had melted, and the pain was caused by the blade touching the acetabulum. The patient will undergo re-surgery for tha on (b)(6) 2021. It was unknown if the re-surgery completed successfully. No further information is available. This complaint involves (4) devices. This report is for (1) tfna helical blade l85 tan. This report is 3 of 4 for (b)(4).
 
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Brand NameTFNA HELICAL BLADE L85 TAN
Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
1302 wrights lane east
west chester 19380
6107195000
MDR Report Key12522546
MDR Text Key273132568
Report Number8030965-2021-07967
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K131548
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.038.285S
Device Lot Number38P6902
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/30/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/31/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 09/23/2021 Patient Sequence Number: 1
Treatment
LOCKSCR 5 L32 F/NAILS TAN LIGHT GREEN; TFNA END CAP EXTENS. 0 TAN; TFNA FEM NAIL Ø10 125° L170 TIMO15
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