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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL HUMERAL NAIL T2 HUMERUS Ø8X250 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL HUMERAL NAIL T2 HUMERUS Ø8X250 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 18300825S
Device Problems Break (1069); Mechanical Problem (1384)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 06/13/2016
Event Type  malfunction  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report. Device is not available.
 
Event Description
The customer reported that they inserted a left humeral nail, there was then difficulty with distal locking the nail. Upon removing the targeting device, it was noticed that the humeral nail itself was damaged insitu. The surgery was completed upon removing the debris with a standard approach. An end cap was placed on the nail, and the wound was closed. Item remained insitu within the patient. Debris pieces unable to be attained as damaged upon removing from patient.
 
Manufacturer Narrative
Product inquiry stated the humeral nail t2 humerus ø8x250 mm to be the subject product. No further associated products were reported. Review of the device history records revealed no discrepancies. The item reported was documented as faultless prior to distribution. A physical examination of the item could not be carried out as the device was not received for evaluation (implanted). From previous cases we have known that a damage of the nail reception may occur when the nail is fixed onto the target device in a wrong position, i. E. That the pegs of the nail adapter had been placed on the rim of the nail instead of being inserted into the intended position in the reception of the nail. Furthermore the breakage of the nail reception might occur when the nail holding screw was not sufficiently tightened during rotating the target device in order to advance the nail to its desired position as a positive (frictional) connection between nail and nail adapter was not achieved. This is consistent with the received information. According to information received two seating slots of the nail reception snapped off most likely due to the nail holding screw becoming loose. When the targeting arm was moved during distal locking the seating slots broke off as a positive (frictional) connection between nail and nail adapter was no longer given. The broken seating slots could be removed from the patient. The attending surgeon did not believe that a nail exchange would be required. Based on the above information the root cause of the reported event was not linked to a deficiency of the device, but was rather user related. Review of complaint history, capa databases and risk analysis 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.
 
Event Description
The customer reported that they inserted a left humeral nail, there was then difficulty with distal locking the nail. Upon removing the targeting device, it was noticed that the humeral nail itself was damaged insitu. The surgery was completed upon removing the debris with a standard approach. An end cap was placed on the nail, and the wound was closed. Item remained insitu within the patient. Debris pieces unable to be attained as damaged upon removing from patient.
 
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Brand NameHUMERAL NAIL T2 HUMERUS Ø8X250 MM
Type of DeviceROD, 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 Key5753835
MDR Text Key48948515
Report Number0009610622-2016-00322
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
K032523
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/13/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/30/2020
Device Catalogue Number18300825S
Device Lot NumberK037A61
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/01/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/27/2016 Patient Sequence Number: 1
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