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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø10X280MM X 120°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø10X280MM X 120°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 34200280S
Device Problem Insufficient Information (3190)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 10/22/2018
Event Type  Injury  
Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.
 
Event Description
On (b)(6) 2018: removal of nail remained in the patient's body was done.However, the distal part of the nail was not removed and it was left and chs implant (synthes) was deployed.Rev # 2.
 
Event Description
On (b)(6) 2018: removal of nail remained in the patient's body was done.However, the distal part of the nail was not removed and it was left and chs implant (synthes) was deployed.Rev # 2.
 
Manufacturer Narrative
The reported event of nail breakage could be confirmed.According to available information the gamma3 nail had broken after an implantation period of approx.8 months.One requirement for successful nail treatment is a timely bone healing in order to relieve the nail over the progressing time of implantation.Potential adverse effects, e.G.Overweight, increased loading or material damage are clearly pointed out in the labeling.In this case the item broke in a fatigue manner after an implantation period of approximately 8 months.From technical point of view the lateral edge of the anterior web had been damaged intra operatively by deviation of the step drill ¿ causing chamfer like material removal.This damage had weekend the material in such a way that tensile stresses had initiated an incipient crack.During usual load bearing the crack had progressed towards medial and separated finally in a residual fracture.A medical assessment was not possible due missing medical records.No indications of material, manufacturing or design related problems were found during the investigation.Review of complaint history, capa databases and risk analysis did not identify any conspicuity.The review of the risk assessment for the failure mode indicated nail breakage was addressed adequately.There were no actions in place related to the reported event for the subject product.No nonconformity was identified.Intra-operative damage, also pointed out in the labeling, was regarded being user related.Further, it could not be determined whether bone healing was sufficient after 6 months or more.With available information the event was not linked to a deficiency of the device.In case further information should become available, we reserve the right to update the investigation and change the root cause.
 
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Brand Name
LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø10X280MM X 120°
Type of Device
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
MDR Report Key8081334
MDR Text Key127536193
Report Number0009610622-2018-01406
Device Sequence Number1
Product Code HSB
UDI-Device Identifier04546540375186
UDI-Public04546540375186
Combination Product (y/n)N
PMA/PMN Number
K034002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 03/11/2019
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 Date11/30/2019
Device Catalogue Number34200280S
Device Lot NumberK04BE1C
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/22/2018
Initial Date FDA Received11/16/2018
Supplement Dates Manufacturer Received02/11/2019
Supplement Dates FDA Received03/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age79 YR
Patient Weight56
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