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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 Information (3190)
Event Date 04/05/2017
Event Type  malfunction  
Manufacturer Narrative
The evaluation revealed the package of the gamma3 nail to be the primary product. No deviations were found during review of the manufacturing, packaging and inspection documents (dhr). The nail returned was documented as faultless prior to distribution. During investigation no visual or manufacturing related issues were found. The reported event was confirmed; water damages were visible on the upper carton box. The shrink foil was inspected; three small holes were observed within the sealed seam. Through these holes water got into the shrink foil and damaged the carton box. The holes in the shrink foil seam are within specification; according to a packaging expert from r&d the shrink foil is not waterproof; it is designed to keep the upper and lower carton box together and shall prevent against generally environmental issues like dust and dirt. The size of the damage indicated that a lot of water got into the shrink foil, more water than expected during rain. Therefore it is very likely that the package was dropped or placed into water (i. E. Water puddle, roadside ditch, wet truck canvas cover). Because no packaging damages were detected in the dhr the case is attributed to an inadequate transport and/or storage out of manufacturers¿ control (user related). Review of complaint history, capa databases, risk analysis and labelling 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
During the receiving process at stryker escs bv in venlo it was noticed that there are signs of undefined dried liquids on the product packaging under the sealing foil.
 
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
During the receiving process at stryker escs bv in venlo it was noticed that there are signs of undefined dried liquids on the product packaging under the sealing foil.
 
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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
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6542608
MDR Text Key251723940
Report Number0009610622-2017-00132
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 company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date02/28/2022
Device Catalogue Number31251180S
Device Lot NumberK01D993
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/11/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/30/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/15/2017
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: 05/03/2017 Patient Sequence Number: 1
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