MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X40 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18965040S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/19/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Referring to the product inquiry the locking screw, fully threaded t2 tibia ø5x40 mm [packaging] is stated to be the primary product.No further associated products were reported.The device resp.Packaging reported was not returned to stryker (b)(4) and thus, a physical examination of the subject device was impossible.Below report is based on available information, only.Review of the manufacturing documents revealed no discrepancies; the item was documented as faultless prior to distribution.Foam particles on implants inside of packages are known from previous complaints.It is possible that the implants abrade particles from the foam blocks due to movements during transport.This issue was already evaluated by a hcp in a similar case.Excerpt of medical statement: ¿[¿] dispersion of foam particles on the surface [¿] it has to be clarified whether small foam particles would cause any harm if they are inserted to a human body together with the (implant).The utilized material ldpe has no cytoxic effects and is well known as biocompatible.It is used as a negative control in cytotoxity test [¿] therefore, if sterility of the packaging is sustained, it is assumed that no negative side effects occur, if smaller particles are unintended inserted into the bone marrow cavity or the surrounded tissue [¿]¿ however, not enough information is available to confirm the reported case.It could not be excluded that the contamination occurred at the user site during opening/handling of the device.Based on the information given an exact root cause could not be determined.Review of complaint history, capa databases and risk analysis did not identify any conspicuity.The review of the risk assessment for the failure mode indicated the issue was addressed adequately.There are no actions in place related to the reported event for the subject product.The file will be closed formally in accordance to our procedures.In case the item and / or substantive information will become available in future the file will be reviewed and reopened.No non-conformity was identified.Device is not available.
Event or Problem Description
A white foreign body ( like foam) in a package.Dr.Used spare.

• Brand Name: LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X40 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: 5955526
• Report Number: 0009610622-2016-00430
• Device Sequence Number: 19003037
• Product Code: HSB
• UDI-Device Identifier: 04546540202499
• UDI-Public: 0104546540202499111510211720093010K0D4E0A
• Combination Product (Y/N): N
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 08/19/2016

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: 09/30/2020
• Device Catalogue Number: 18965040S
• Device Lot Number: K0D4E0A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2016
• Initial Report FDA Received Date: 09/16/2016
• 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