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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 Ø5X55 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X55 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 18965055S
Device Problem Device Expiration Issue (1216)
Patient Problem No Information (3190)
Event Date 06/12/2017
Event Type  malfunction  
Manufacturer Narrative
The locking screw, fully threaded t2 tibia ø5x55 mm was not returned to stryker kiel since the issue is about an exceeded expiry date and physical examination was not required. Review of the device history records of the device reported did not indicate any conspicuities; the dhr contain a copy of the label set (label for packaging and patient record label). All labels indicate end of shelf life by (end of) april 2017 (nominal value). The device reported was documented as faultless prior to distribution. Since the reported locking screw was on consignment at the time of surgery, the distribution center is responsible for the exceeded expiry date which should have been noticed prior to surgery. Evaluation indicates the event being an error on part of the distribution center. 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. 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. A consultant hcp stated in a similar case that a risk for the patient is not to be expected although an expired nail (exceeded by approx. 6 months) 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. The quality assurance associate, department quality and operations [stryker (b)(6)] was informed about the case in order to address the issue. Evaluation revealed evidence that the event is not linked to a deficiency of the device but is rather related to off-label use [error on part of the distribution center].
 
Event Description
Expired implant was implanted into a patient.
 
Manufacturer Narrative
Device will not be returned. If additional information becomes available it will be provided on a supplemental report. Device implanted.
 
Event Description
Expired implant was implanted into a patient.
 
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Brand NameLOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X55 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 Key6687397
MDR Text Key251720395
Report Number0009610622-2017-00207
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeAU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/02/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/05/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2017
Device Catalogue Number18965055S
Device Lot NumberK123745
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/05/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2012
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: 07/05/2017 Patient Sequence Number: 1
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