MAUDE Adverse Event Report: STRYKER TRAUMA KIEL ADVANCED LOCKING SCREW IMN SCREWS Ø5X45MM; SCREW, FIXATION, BONE

Catalog Number	23615045S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Injury (2348); Ambulation or Postural Difficulties (2544); No Patient Involvement (2645)
Date of Event	06/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device remains implanted at this time.
Event or Problem Description
Product manager reported that : " in the 3-month radiographic examination after surgery with t2 alpha tibia nail: there are two advanced t2 alpha screws that have begun to move." additional information reported: removal of the screw is planned septic pseudarthrosis of the tibia: surgery with external fix and then by evolutive nail since 1y.Alpha nail implanted on (b)(6) 2019.Retreat of the 2 medial lateral distal screws at 1 month.Standard distal anterior posterior distal screw (not advanced).Event identified post-operative.Patient involvement: yes; walk without support promulgated for an additional 6 weeks.
Additional Manufacturer Narrative
The reported event could be confirmed, since provided x-ray images show the migrated screw.Based on investigation and provided medical statement it could not be excluded that the reported event is related to the clearly visible inactivity osteoporosis.The failure was caused by patient factors.The device inspection revealed the following: a device inspection was not possible since the affected device was not returned and no other evidence was provided for investigation.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.
Event or Problem Description
Product manager reported that : " in the 3-month radiographic examination after surgery with t2 alpha tibia nail: there are two advanced t2 alpha screws that have begun to move." additional information reported: removal of the screw is planned.Septic pseudarthrosis of the tibia : surgery with external fix and then by evolutive nail since 1y.Alpha nail implanted on (b)(6) 2019.Retreat of the 2 medial lateral distal screws at 1 month.Standard distal anterior posterior distal screw (not advanced).Event identified post-operative.Patient involvement : yes; walk without support promulgated for an additional 6 weeks.

• Brand Name: ADVANCED LOCKING SCREW IMN SCREWS Ø5X45MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 9194937
• Report Number: 0009610622-2019-00869
• Device Sequence Number: 18944407
• Product Code: HWC
• UDI-Device Identifier: 07613327381665
• UDI-Public: 07613327381665
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K191271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 23615045S
• Device Lot Number: K069365
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/19/2019
• Supplement Date Received by Manufacturer: 12/09/2019
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 01/08/2020
• 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: Required Intervention
• Patient Age: 42 YR
• Patient Weight: 80