MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW, FULLY THREADED T2 TIBIA Ø4X30MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1896-4030S
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "during opening of the screw packaging a foreign body was visualised by the scrub nurse, myself and the scout nurse.The screw and foreign body were removed into a specimen jar and collected for return to stryker for investigation.There was no delay in surgery and no impact on the patient as the screw was not implanted and was quarantined within a separate area of the aseptic field.A second screw of the same size was opened and implanted.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "during opening of the screw packaging a foreign body was visualised by the scrub nurse, myself and the scout nurse.The screw and foreign body were removed into a specimen jar and collected for return to stryker for investigation.There was no delay in surgery and no impact on the patient as the screw was not implanted and was quarantined within a separate area of the aseptic field.A second screw of the same size was opened and implanted.".
Additional Manufacturer Narrative
The reported event could not be confirmed, since the item was received in already unpacked condition and with missing original packaging.The returned part was received in a plastic jar inside a plastic pouch with the inscription « biological hazard.Detailed inspection through transparent plastic jar revealed only an unpacked locking screw but no pollution like hair.However, a foreign material in original condition could not be verified as the device was already unpacked and no evidence of pollution in original condition was provided.However, no evidence [like a photo] is available to confirm the foreign material in original condition and it could not be excluded that the pollution occurred at the user site during opening/handling of the device.The ifu instructs that inspection is recommended prior to surgery.Presence of pollution in original condition could have been best presented in unopened condition as it is obviously visible through the clear blister.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.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.

• Brand Name: LOCKING SCREW, FULLY THREADED T2 TIBIA Ø4X30MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17306155
• Report Number: 0009610622-2023-00232
• Device Sequence Number: 17768839
• Product Code: HSB
• UDI-Device Identifier: 04546540202345
• UDI-Public: 04546540202345
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K203819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2023

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 Model Number: 1896-4030S
• Device Catalogue Number: 18964030S
• Device Lot Number: K0FFBA4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/18/2023
• Supplement Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown