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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL NAIL ADAPTER T2 TIBIA SPI ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL NAIL ADAPTER T2 TIBIA SPI ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 18061402
Device Problems Device Operates Differently Than Expected (2913); Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/08/2016
Event Type  malfunction  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
It was reported that while trailing the instrumentation with sawbones, the nail adapter would not properly seat into the fittings on the nail, and the nail holding screw would not engage properly into the nail threadings. Due to these circumstances the instrumentation would not function properly in a live case.
 
Manufacturer Narrative
The evaluation revealed both instruments to be the primary products. No deviations were found during review of the manufacturing and inspection documents (dhr). The instruments were documented as faultless prior to distribution. An investigation was not possible because the instruments were not provided. The root cause could not be determined. The customer reported that the nail adapter would not properly seat into the fittings on the nail, and the nail holding screw would not engage properly into the nail threading¿s. Most likely the nail adapter connection profile was deformed (user related); in that case an attachment of the nail and nail holding screw (nhs) is no longer possible. If fretting of the nhs occurred within the nail adapter could not be excluded. (b)(4) was initiated, resulting in a 100% inspection, implemented in (b)(6) 2013. Both instruments were manufactured to a time where the action was already in place. A more precise evaluation was not possible based on the given information. 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
It was reported that while trailing the instrumentation with sawbones, the nail adapter would not properly seat into the fittings on the nail, and the nail holding screw would not engage properly into the nail threadings. Due to these circumstances, the instrumentation would not function properly in a live case.
 
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Brand NameNAIL ADAPTER T2 TIBIA SPI
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 Key5698612
MDR Text Key47600108
Report Number0009610622-2016-00283
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131365
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 05/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number18061402
Device Lot NumberK0B9CD6
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/02/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/01/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 06/03/2016 Patient Sequence Number: 1
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