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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X52,5 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X52,5 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 18965052S
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/29/2017
Event Type  malfunction  
Manufacturer Narrative
The returned device matched the report and the complaint failure mode was confirmed. Referring to product inquiry the locking screw, fully threaded t2 tibia ø5x52,5 mm [packaging] is stated to be the primary product. No further associated products were reported. A review of the dhr revealed no discrepancies, in particular during the packaging process. During visual inspection a hair outside the sterile barrier between overwrap-foil and cardboard box could be verified. All seals and original packaging are still intact. Thus, the pollution must have occurred during the packaging process at our sub-supplier, which was not detected during inspection. Based on the above facts the root cause of the reported event is related to an inadequate packaging process. 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. The found hair has to be classified as a non-conformance. This case has to be classified as a non-conformance and ncr has been initiated for further root cause investigation.
 
Event Description
During the receiving process at stryker escs bv in venlo it was noticed that the product was received with a hair 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 the product was received with a hair under the sealing foil.
 
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Brand NameLOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X52,5 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 Key6731361
MDR Text Key251446565
Report Number0009610622-2017-00232
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K003018
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 Received07/21/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2022
Device Catalogue Number18965052S
Device Lot NumberK09435A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/14/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/21/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/07/2017
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: 07/21/2017 Patient Sequence Number: 1
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