MAUDE Adverse Event Report: STRYKER TRAUMA KIEL ADVANCED LOCKING SCREW IMN SCREWS 5X45MM; SCREW, FIXATION, BONE

Model Number	2361-5045S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	03/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device was discarded.
Event or Problem Description
This report is for the first screw back-out ("the most distal t2 alpha screw").As reported: "the most distal t2 alpha screw in the tibia nail backed out and had to be removed.The screw was an advanced locking screw and was removed in clinic.Two days later, the other 2 distal screws (advanced locking screws) also backed out.This event happened 2 and 2.5 weeks post op".
Additional Manufacturer Narrative
Correction: refer to h6 patient code.The reported event, implant - migration, was confirmed on provided x-rays.Review of device history, labelling, capa databases and risk analysis did not identify any discrepancies.There are no open actions in place related to the reported event for the subject product(s).No indications of material, manufacturing or design related problems were found during the document review.A device inspection was not possible since the affected device was disposed of by the hospital.X-ray images were provided and reviewed by an hcp.In his opinion the combination of negative factors (e.G.Strange bone structure, unstable fracture pattern, small nail in wide cavity) may have contributed to the loosening/back out of the screw.Based on investigation and provided medical statement it could not be excluded that the reported event is related to patient factors contributed by the kind of treatment.In case essential information becomes available we reserve the right to re-reopen the case for investigation and to assess a new root cause.
Event or Problem Description
This report is for the first screw back-out ("the most distal t2 alpha screw").As reported: "the most distal t2 alpha screw in the tibia nail backed out and had to be removed.The screw was an advanced locking screw and was removed in clinic.Two days later, the other 2 distal screws (advanced locking screws) also backed out.This event happened 2 and 2.5 weeks post op".

• Brand Name: ADVANCED LOCKING SCREW IMN SCREWS 5X45MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; DE D-24232
• MDR Report Key: 9941552
• Report Number: 0009610622-2020-00141
• Device Sequence Number: 16666404
• Product Code: HWC
• UDI-Device Identifier: 07613327381665
• UDI-Public: 07613327381665
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K191271
• 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,Followup
• Report Date (Section B): 07/09/2020

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/30/2023
• Device Model Number: 2361-5045S
• Device Catalogue Number: 23615045S
• Device Lot Number: K059D72
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/13/2020
• Supplement Date Received by Manufacturer: 06/12/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 07/09/2020
• 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