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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 Ø5X40 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X40 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 18965040S
Device Problem Device Expiration Issue (1216)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/30/2016
Event Type  malfunction  
Manufacturer Narrative
Device will not be returned. If additional information becomes available it will be provided on a supplemental report.
 
Event Description
It was reported that expired item was implanted on (b)(6) case. Rep was not present.
 
Manufacturer Narrative
Referring to the product inquiry the locking screw, fully threaded t2 tibia ø5x40 mm is the only reported device and thus considered the primary product. The locking screw reported remains implanted. The issue is about an exceeded expiry date and physical examination is not required. Review of the device history records of the locking screw reported did not indicate any conspicuity. The dhr contain a copy of the label set (label for packaging and patient record label); all labels indicate end of shelf life by may 2016 (nominal value). The device reported was documented faultless prior to distribution. In the case presented a locking screw, fully threaded t2 tibia ø5x40 mm was implanted whose sterilization date was exceeded by 30 days (expiration date: 31. 05. 2016; date of implantation: (b)(6) 2016). Real aging tests performed with stryker implants in 2007 reveal that there is a safety tolerance; implants with exceeded expiry date were checked more than 1 year overdue and considered still sterile subsequently. Thus, in this specific case of exceeded expiry date by 30 days a risk for the patient is not to be expected. A consultant hcp stated in a similar case that a risk for the patient is not to be expected although an expired nail had been implanted. The expiry date is a theoretical date, which offers a high level of safety and the risk of an infection caused by a simple transgression of the expiry date is negligible. Nevertheless, the expiry date of the reported locking screw should have been noticed prior to surgery as it is always to be noticed on the label. According to the sales rep the implant was hospital-owned inventory at the time of implantation. Evaluation revealed evidence that the event is not linked to a deficiency of the device but is rather related to misuse. The root cause of the event is in the field of responsibility of the user. No non-conformity in terms of product quality was identified.
 
Event Description
It was reported that expired item was implanted on (b)(6) case. Rep was not present.
 
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Brand NameLOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X40 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
rose haas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5842707
MDR Text Key51061146
Report Number0009610622-2016-00380
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K032244
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 07/07/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/03/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2016
Device Catalogue Number18965040S
Device Lot NumberK916141
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/17/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/30/2011
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: 08/03/2016 Patient Sequence Number: 1
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