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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TARGETING ARM FEMUR GT T2 ALPHA FEMUR ANTEGRADE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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STRYKER TRAUMA KIEL TARGETING ARM FEMUR GT T2 ALPHA FEMUR ANTEGRADE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 2353-3103
Device Problem Failure to Align (2522)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/28/2020
Event Type  malfunction  
Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
 
Event Description
The customer reported that the t2 alpha targeting device was in use during a procedure and the surgeon set the nail up on the jig, checked alignment.The nail was inserted into the patient, then the k wire was placed through the sleeve and jig, but the k wire missed the nail.The surgeon noticed instantly on the x-ray and readjusted the jig and sleeve, re-fired the k wire and then surgery continued.The case was completed without delay.
 
Manufacturer Narrative
The reported event ¿ instrument - misaligned wire ¿ could not be confirmed.Incoming inspection and the dhr of the reported the returned device revealed no manufacturing discrepancies.The review of risk file, labelling and nc-database revealed no observations.Reasons for mal alignment between k-wire and nail drill holes are various, e.G.(but not limited to) insufficient tightening of the nail holding screw, applying too much (axial) force on the construct during drilling or unsuitable bone geometry.Functional check prior to use is required in the labelling ¿ such as ifu, op-tech and re-processing brochure.According to the event description (successful functional check prior to use) reveals either handling deviation during drilling or difficult bone structure of the patient.Functional test of returned products with sample products revealed no deficiency in targeting accuracy.With the available information provided a root cause could not be determined.
 
Event Description
The customer reported that the t2 alpha targeting device was in use during a procedure and the surgeon set the nail up on the jig, checked alignment.The nail was inserted into the patient, then the k wire was placed through the sleeve and jig, but the k wire missed the nail.The surgeon noticed instantly on the x-ray and readjusted the jig and sleeve, re-fired the k wire and then surgery continued.The case was completed without delay.
 
Event Description
The customer reported that the t2 alpha targeting device was in use during a procedure and the surgeon set the nail up on the jig, checked alignment.The nail was inserted into the patient, then the k wire was placed through the sleeve and jig, but the k wire missed the nail.The surgeon noticed instantly on the x-ray and readjusted the jig and sleeve, re-fired the k wire and then surgery continued.The case was completed without delay.
 
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Brand Name
TARGETING ARM FEMUR GT T2 ALPHA FEMUR ANTEGRADE
Type of Device
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
DE  D-24232
MDR Report Key9863018
MDR Text Key191535776
Report Number0009610622-2020-00121
Device Sequence Number1
Product Code HSB
UDI-Device Identifier07613327338652
UDI-Public07613327338652
Combination Product (y/n)N
PMA/PMN Number
K191271
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup,Followup
Report Date 08/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2353-3103
Device Catalogue Number23533103
Device Lot NumberKP423047 0016
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/11/2020
Initial Date Manufacturer Received 02/28/2020
Initial Date FDA Received03/20/2020
Supplement Dates Manufacturer Received05/27/2020
07/28/2020
Supplement Dates FDA Received06/17/2020
08/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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