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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL RECONSTRUCTION NAIL R1.5, TI, RIGHT T2 RECON Ø10X320 MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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STRYKER TRAUMA KIEL RECONSTRUCTION NAIL R1.5, TI, RIGHT T2 RECON Ø10X320 MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 18451032S
Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)
Patient Problem Non-union Bone Fracture (2369)
Event Date 05/16/2017
Event Type  Injury  
Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device was discarded.
 
Event Description
Primary surgery using t2r was performed on (b)(6) 2014.After that the fracture did not heal and revision surgery using g3l was performed on (b)(6) 2017.During g3l surgery, as lag screw guide wire induced to the hole of the t2r lag screw, it was not inserted properly.The surgeon gave up the step drill procedure and inserted u-lag screw to the patient.Also the u-lag screw was not inserted properly, the tip of the u-lag screw driver broke after repeated trial and error.The surgery was finished with the screw projecting to lateral slightly.U-blade and u-endcap were not used.This pi to cover the revision surgery and related to (b)(4).
 
Manufacturer Narrative
The evaluation revealed the t2 recon nail to be the primary product.No deviations were found during review of the manufacturing and inspection documents (dhr).The nail was documented as faultless prior to distribution.An investigation was not possible because the nail and x-rays were not available.According to the customer the bone fracture did not heal after a period of approx.2,6 years; the explanted nail was not broken.It can be assumed that the nail was not damaged and did not contribute to the not healed fracture.According to stryker internal literature research (statement (b)(4)) bone fractures of femur bones have a normal healing range of approx.6 months, a healing period of >6 months can be classified as non-union.Non-unions can have several reasons and are listed as adverse effects in the ifu.Based on the given information and the fact that no manufacturer related issues were found the case was classified to be patient related (non-union).Review of complaint history, capa databases, risk analysis and labeling did not identify any discrepancies.There are no open actions in place related to the reported event for the subject product(s).No non-conformity was identified.Device was not received.
 
Event Description
Primary surgery using t2r was performed on (b)(6) 2014.After that the fracture did not heal and revision surgery using g3l was performed on (b)(6) 2017.During g3l surgery, as lag screw guide wire induced to the hole of the t2r lag screw, it was not inserted properly.The surgeon gave up the step drill procedure and inserted u-lag screw to the patient.Also the u-lag screw was not inserted properly, the tip of the u-lag screw driver broke after repeated trial and error.The surgery was finished with the screw projecting to lateral slightly.U-blade and u-endcap were not used.This pi to cover the revision surgery and related to pi (b)(6).
 
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Brand Name
RECONSTRUCTION NAIL R1.5, TI, RIGHT T2 RECON Ø10X320 MM X 125°
Type of Device
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6625498
MDR Text Key77211438
Report Number0009610622-2017-00180
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K102992
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/03/2017
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 Lay User/Patient
Device Expiration Date06/30/2018
Device Catalogue Number18451032S
Device Lot NumberK04211C
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/16/2017
Initial Date FDA Received06/08/2017
Supplement Dates Manufacturer Received07/11/2017
Supplement Dates FDA Received08/03/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2013
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 Age77 YR
Patient Weight44
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