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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH CANNULATED SCREW ASNIS III Ø5.0X80MM TL27MM SCREW, FIXATION, BONE

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STRYKER GMBH CANNULATED SCREW ASNIS III Ø5.0X80MM TL27MM SCREW, FIXATION, BONE Back to Search Results
Catalog Number 601680S
Device Problems Device Packaging Compromised (2916); Compatibility Problem (2960)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/19/2014
Event Type  Malfunction  
Event Description

According to the customer, when they opened the implant box for item (b)(4) asnis screw, but instead of the one they expected, they found asnis screw (b)(4) in the implant box.

 
Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

 
Manufacturer Narrative

The reported event of the product mix issue could be confirmed, since the box was received and the device found inside it did not report the same references of the box. According to the investigation, the root cause was attributed to a user-related issue. From a review of the manufacturing documents of both involved lots it resulted that the reference reported on the box (f02570) was manufactured on 08-mar-2014, whereas the screw found in it (f34104) on 25-oct-2014. According to our quality engineer, the significant amount of days between these two dates makes become impossible the likelihood that there was mix-up during laser marking/packaging. Therefore stryker is considered not at fault of such event. Consequently, it results very likely that the event is user-related. Two factors support this: - only the screw, the external package and the ifu were received. No inner blister nor patient record label were returned. - on 01/13/2015 one screw of lot f02570 on stock in (b)(4) was checked. Packaging and labeling were found to be correct. A review of the device history for the reported lots did not indicate any abnormalities. No corrective actions are required at this time. A review of the labeling did not indicate any abnormalities. No corrective actions are required at this time. No indications of material, manufacturing or design related problems were found during the investigation.

 
Event Description

According to the customer, when they opened the implant box for item 601680s asnis screw, but in stead of the one they expected, they found asnis screw 602680s in the implant box.

 
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Brand NameCANNULATED SCREW ASNIS III Ø5.0X80MM TL27MM
Type of DeviceSCREW, FIXATION, BONE
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH 2545
Manufacturer (Section G)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH 2545
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key4415743
MDR Text Key5163364
Report Number0008031020-2015-00026
Device Sequence Number1
Product Code HWC
Combination Product (Y/N)N
Reporter Country CodeDA
PMA/PMN NumberK000080
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/19/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/14/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number601680S
Device LOT NumberF02570
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/13/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/15/2015
Was Device Evaluated By Manufacturer? No
Date Device Manufactured03/07/2014
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: 01/14/2015 Patient Sequence Number: 1
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