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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 31251180S
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/17/2017
Event Type  malfunction  
Manufacturer Narrative
Evaluation revealed the received trochanteric nail kit, ti gamma3® ø11x180mm x 125° (packaging) to be the primary product. Review of the dhr revealed no discrepancies, in particular in the packaging process. The reported event could not be reproduced as the packaging was received in opened condition (broken sealing). Pollution in original condition could not be verified. Upon receipt of the device the reported hair was found at the area of the originally sealed rim, fixed by a scotch tape, and should have been noticed prior to opening as it is visible through the clear blister. Due to adhesive power of the glued / sealed connection of tyvek - blister a white colored area remains on the blister when the tyvek® lid is torn off. This white area is called crazing resp. Stress whitening. A consistent white and not interrupted surface indicates that no sealed in foreign material (e. G. Hair) at the sealed area of the blister rim was present. In case of a sealed in hair a negative imprint would be apparent at the stress whitening. Furthermore, not enough information is available to confirm the reported case (like a photo of the unopened package). It could not be excluded that the pollution occurred at the user site. Based on the above observations the root cause could not be determined. No discrepancies were detected during risk analysis review. No nonconformity was identified.
 
Event Description
Upon opening the sterile packaging of gamma nail, a hair was found in the seal of the package. The rep was not in the case.
 
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
Upon opening the sterile packaging of gamma nail, a hair was found in the seal of the package. The rep was not in the case.
 
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Brand NameTROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM 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
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer Contact
rose haas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6867199
MDR Text Key256803803
Report Number0009610622-2017-00284
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K034002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2022
Device Catalogue Number31251180S
Device Lot NumberK0843BC
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/10/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/04/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/31/2017
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: 09/14/2017 Patient Sequence Number: 1
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