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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH ARTHRODESIS NAIL, RIGHT T2 KNEE ARTHRODESIS Ø11.5 X 740MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER GMBH ARTHRODESIS NAIL, RIGHT T2 KNEE ARTHRODESIS Ø11.5 X 740MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 18291174S
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
Patient Problem Non-union Bone Fracture (2369)
Event Date 08/01/2018
Event Type  Injury  
Manufacturer Narrative
Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition unknown.
 
Event Description
Patient called stating she had a t2 nail implanted in her right knee in (b)(6) 2017.In (b)(6) 2018, a screw was removed from the nail and bone cement applied due to non-union.
 
Event Description
Patient called stating she had a t2 nail implanted in her right knee in (b)(6) of 2017.In (b)(6) of 2018, a screw was removed from the nail and bone cement applied due to non-union.
 
Manufacturer Narrative
Correction - please refer to d1 product long description, d2a, d2b, d3, g1 reporting contact.The anatomical location of the described event narrows down the applicable device to a t2 femur nail.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.If the device is returned or if any additional information is provided, the investigation will be reassessed.Update april 2024: the patient contacted stryker in 2024 to request the material composition of the implants (t2 nail as well as the cement used during her procedure).The material composition of catalog number 18291174 (arthrodesis nail, right t2 knee arthrodesis 011.5 x 740mm) was provided.This device is made of titanium (ti6 al 4v eli) that includes the following elements : chemical composition (mass ): carbon (c) - 0.08, aluminum (ai) - 5.5 ¿ 6.5, vanadium (v) 3.5 ¿ 4.5, iron (fe) - 0.25, oxygen (o) - 0.13 , nitrogen (n) - 0.05, hydrogen (h) - 0.012a , titanium (ti) ¿ balance.If the device is returned or if any additional information is provided, the investigation will be reassessed.
 
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Brand Name
ARTHRODESIS NAIL, RIGHT T2 KNEE ARTHRODESIS Ø11.5 X 740MM
Type of Device
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
SZ  2545
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM   D-24232
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key8861470
MDR Text Key153380979
Report Number0009610622-2019-00603
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K020384
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/23/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number18291174S
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/16/2019
Initial Date FDA Received08/05/2019
Supplement Dates Manufacturer Received05/01/2024
Supplement Dates FDA Received05/23/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age61 YR
Patient SexFemale
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