MAUDE Adverse Event Report: STRYKER GMBH CANNULATED SCREW, PARTIALLY THREADED ASNIS III Ø6.5X100MM TL20MM; SCREW, FIXATION, BONE

Catalog Number	602700S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that the powder like a metal were came out from the lumen of screw in unpacking.It was changed to other one and the procedure was successful without other problem.
Event or Problem Description
It was reported that the powder like a metal were came out from the lumen of screw in unpacking.It was changed to other one and the procedure was successful without other problem.
Additional Manufacturer Narrative
The reported event that cannulated screw, partially threaded asnis iii ø6.5x100mm tl20mm was alleged of 'contamination of the packaging' could not be confirmed, since the original packaging was not returned for evaluation and no other evidences were provided.The device as such is conforming to specifications and is fully functional.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.The device inspection revealed the following: unfortunately the original packaging was not returned for investigation and also no pictures were taken or made available of the reported / mentioned substance.Looking closely (using the microscope) we found only one plastic like debris on the entire screw.We could only suspect though, that due to multiple handling of the plastic pouch some debris during shipping / storage could have been possible (manufactured in september 2016).A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.

• Brand Name: CANNULATED SCREW, PARTIALLY THREADED ASNIS III Ø6.5X100MM TL20MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8287400
• Report Number: 0008031020-2019-00056
• Device Sequence Number: 1991266
• Product Code: HWC
• UDI-Device Identifier: 04546540087874
• UDI-Public: 04546540087874
• Combination Product (Y/N): N
• PMA/510(K) Number: K000080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 602700S
• Device Lot Number: V30689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Initial Date Received by Manufacturer: 01/07/2019
• Supplement Date Received by Manufacturer: 03/04/2019
• Initial Report FDA Received Date: 01/29/2019
• Supplement Report FDA Received Date: 03/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other