MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X90 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18965090S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported that a hair was discovered inside the sterile packaging of the screw.Procedure was completed successfully with no surgical delay or adverse consequences reported.
Additional Manufacturer Narrative
The reported event could not be confirmed.A review of the dhr revealed no discrepancies, in particular in the packaging process.The item returned was documented as faultless prior to distribution.The reported event could not be reproduced as the packaging was received in opened condition (broken sealing).Pollution in original condition could not be verified.Upon receipt of the device the reported hair was found at the outside of the foam layer and should have been noticed prior to opening as it is visible through the clear blister.Furthermore, not enough information is available to confirm the reported case (like a photo of the unopened package).It could not be excluded that the pollution occurred at the user site.Based on the above observations the root cause could not be determined.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.
Event or Problem Description
It was reported that a hair was discovered inside the sterile packaging of the screw.Procedure was completed successfully with no surgical delay or adverse consequences reported.

• Brand Name: LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X90 MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 9073048
• Report Number: 0009610622-2019-00693
• Device Sequence Number: 2272387
• Product Code: HSB
• UDI-Device Identifier: 04546540202598
• UDI-Public: 04546540202598
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K032244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2019

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 Expiration Date: 07/31/2023
• Device Catalogue Number: 18965090S
• Device Lot Number: K0B218D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2019
• Initial Date Received by Manufacturer: 08/20/2019
• Supplement Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 09/16/2019
• Supplement Report FDA Received Date: 12/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1