MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, PARTIALLY THREADED T2 TIBIA Ø5X30 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1891-5030S
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "screw of t2 system did not have the length marked on the package and the screw.".
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: "screw of t2 system did not have the length marked on the package and the screw.".
Additional Manufacturer Narrative
Please note the correction to d9/h3 as the device was not returned for evaluation.The reported event could not be confirmed, since the device was not returned for evaluation and dhr review performed revealed the product to be marked as specified.The device in question was labeled / engraved as intended.The length as per labelling is the nominal length (30 mm).According to the specification the tolerated minor length is 28,5mm.Nevertheless, a physical evaluation could not be performed due to non-returned item and thus, further technical statement impossible.Review of batch records revealed no discrepancies in labelling.Although item was not available for evaluation and thus, could not be physically measured it is known from previous cases that it is rather related due to lack of knowledge by the user.Screw head length was minimized with design change in 2003 to decrease soft tissue irritation.Finally, determination of screw (lengths) is repeatedly described in several chapters within specific operative technique.Based on details available, the root cause was attributed to a user related issue.The failure was caused by user-customer-learning gap errors; lack of knowledge/skill.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.H3 other text : device disposition unknown.

• Brand Name: LOCKING SCREW, PARTIALLY THREADED T2 TIBIA Ø5X30 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; GM D-24232
• 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: 15981885
• Report Number: 0009610622-2022-00581
• Device Sequence Number: 5784552
• Product Code: HSB
• UDI-Device Identifier: 04546540201911
• UDI-Public: 04546540201911
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K203819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2023

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 Expiration Date: 01/31/2026
• Device Model Number: 1891-5030S
• Device Catalogue Number: 18915030S
• Device Lot Number: K01CDD3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2022
• Supplement Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 12/14/2022
• Supplement Report FDA Received Date: 02/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2021
• 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: Female