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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH TFNA FENESTRATED HELICAL BLADE 85MM - STERILE ROD,FIXATION,INTRAMEDULLARY

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SYNTHES GMBH TFNA FENESTRATED HELICAL BLADE 85MM - STERILE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 04.038.385S
Device Problem Migration (4003)
Patient Problem Bone Fracture(s) (1870)
Event Date 01/01/2021
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Additional product code: ktt. Complainant part is not expected to be returned for manufacturer review/investigation. 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 on that (b)(6) 2021, the patient underwent for a revision surgery due to the implant cut-out occurred. It was unknown if the revision surgery completed successfully. The patient outcome was unknown. The patient had orif surgery for the trochanteric femur on (b)(6) 2021. No further information is available. Concomitant device reported: unk - nails: tfna (part#: unknown, lot#: unknown, quantity: 1). Unk - screws: locking (part#: unknown, lot#: unknown, quantity: unknown). This complaint involves (1) device. This report is for (1) tfna fenestrated helical blade 85mm - sterile. This report is 1 of 1 for (b)(4).
 
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Brand NameTFNA FENESTRATED HELICAL BLADE 85MM - STERILE
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
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12482912
MDR Text Key271755885
Report Number8030965-2021-07809
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 company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.038.385S
Device Lot Number95P6445
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 Received09/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/19/2021
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: 09/16/2021 Patient Sequence Number: 1
Treatment
UNK - NAILS: TFNA; UNK - SCREWS: LOCKING
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