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

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.

• Brand Name: CANNULATED SCREW ASNIS III Ø5.0X80MM TL27MM
• Type of Device: SCREW, 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 Key: 4415743
• MDR Text Key: 5163364
• Report Number: 0008031020-2015-00026
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K000080
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• 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 Received: 01/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 601680S
• Device Lot Number: F02570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/15/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/07/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other