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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, STST, RIGHT GAMMA3® Ø11X340MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, STST, RIGHT GAMMA3® Ø11X340MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 42250340S
Device Problem Failure To Adhere Or Bond (1031)
Patient Problem No Code Available (3191)
Event Date 10/10/2017
Event Type  Injury  
Event Description
Risk manager reported the following event to (b)(6), "non union of right femur. Fracture of the long gamma nail implanted at a different hospital (b)(6). Revision to change the nail. ".
 
Manufacturer Narrative
Referring to product inquiry the long nail kit r2. 0, stst, right gamma3® ø11x340mm x 125° is stated to be the primary product. Deviations in material or manufacturing of the affected nail kit returned were not found. Dimensional examination revealed no deviations in the relevant undamaged areas of the nail returned. Thus, we exclude deviations in material and manufacturing. The received nail is completely broken in the webs of the proximal drill hole for the lag screw. According to the damage and the evidences of the breakage surfaces, the nail broke in a fatigue fracture due to axial overload after an unknown implantation period. Material deformation at the medial / distal and the lateral / proximal edge of the lag screw hole (bearing points) indicates high tension forces caused by high axial load, which suggests more than partial weight bearing. The damage at the lateral edge of the anterior web, intra operatively caused by a deviated step drill, had most likely created the starting point of the nail breakage by a notching effect. Furthermore, due to the traces found at the lateral edge of the proximal bore and at the inside of the anterior web, it could not be excluded that the nail breakage was contributed by intra operative damage caused by a deviated step drill. Based on the above the nail breakage is not linked to a deficiency of the device, but is rather considered patient related (insufficient bone healing / nonunion contributed by high axial load) after an unknown implantation period. 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 the issue was addressed adequately. There are no actions in place related to the reported event for the subject product. No nonconformity was identified.
 
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
Risk manager reported the following event to (b)(6), "non union of right femur. Fracture of the long gamma nail implanted at a different hospital (b)(6) hospital in (b)(6). Revision to change the nail. ".
 
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Brand NameLONG NAIL KIT R2.0, STST, RIGHT GAMMA3® Ø11X340MM X 125°
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
MDR Report Key7153304
MDR Text Key285042775
Report Number0009610622-2017-00387
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K034343
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 03/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2015
Device Catalogue Number42250340S
Device Lot NumberK272250
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/08/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/28/2017 Patient Sequence Number: 1
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