MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X60 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1896-5060S
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2021
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
Stryker rep reported that screws measuring shorter than the described length.Screw was implanted and then removed due to being to short.A different screw was used to complete the procedure.The procedure was delayed by 15 min.
Event or Problem Description
Stryker rep reported that screws measuring shorter than the described length.Screw was implanted and then removed due to being to short.A different screw was used to complete the procedure.The procedure was delayed by 15 min.
Additional Manufacturer Narrative
Correction: please refer to d9/h3 - device not returned.The reported event could be confirmed, since the screw on the received picture is shorter than indicated on the label.The received picture was reviewed, the picture shows the 60mm locking screw together with a ruler.The screw on the picture is about 1.5mm shorter than 60mm, which is according to the specification.Based on the drawing the actual measurement of a fully threaded t2 tibia locking screw can indeed be up to 1.5mm shorter than the on the package indicated length.This reduced length of the screw is designed to decrease soft tissue irritation as the screw does protrude less from the far cortex.This is also visible in the t2 tibial nailing system operative technique, the screw on the picture is slightly shorter than the 50mm scale next to it and there is a remark with an asterisk that dimensions are nominal.In the t2 tibial nailing system operative technique; it is also mentioned that depending on the used measuring technique 5mm need to be added to the screw length.A device inspection was not possible since the affected device was not returned, therefore no further evaluation is possible.A device inspection was not possible since the affected device was not returned, therefore no further evaluation is possible.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 the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text : device disposition is unknown.

• Brand Name: LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X60 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: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13156239
• Report Number: 0009610622-2022-00003
• Device Sequence Number: 11799137
• Product Code: HSB
• UDI-Device Identifier: 04546540202536
• UDI-Public: 04546540202536
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K032244
• 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): 02/10/2022

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: 05/31/2026
• Device Model Number: 1896-5060S
• Device Catalogue Number: 18965060S
• Device Lot Number: K092713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/08/2021
• Supplement Date Received by Manufacturer: 01/12/2022
• Initial Report FDA Received Date: 01/04/2022
• Supplement Report FDA Received Date: 02/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2021
• 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: Unknown