MAUDE Adverse Event Report: STRYKER TRAUMA KIEL ADVANCED LOCKING SCREW IMN SCREWS 5X60MM; SCREW, FIXATION, BONE

Model Number	2361-5060S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device remains implanted.
Event or Problem Description
It was reported that on (b)(6) 2021, patient was operated with t2 alpha femoral gt nails and the advanced locking screw backed out after surgery.It is currently under follow-up, but if it comes out any more, the doctor will consider re-operation.
Event or Problem Description
It was reported that on (b)(6) 2021, patient was operated with t2alpha femoral gt nails and the advanced locking screw backed out after surgery.It is currently under follow-up, but if it comes out any more, the doctor will consider re-operation.
Additional Manufacturer Narrative
The reported event could be confirmed, since provided x-ray images show the dislocated screw.A device inspection was impossible due to missing implant [still implanted] and a review of the dhr revealed no discrepancies.However, provided images were forwarded to a medical expert for statement [excerpts]: ¿presumably, the lack of fixation in the second plane has caused minimal movement in the frontal plane.As a result, the screw with the largest clearance/displacement has loosened (distally) and we now see this image.This can also happen with the relatively, but not completely, fixed, angle-stable screws.In my view, the screw in the sagittal plane is missing here in order to fix the construct in the frontal plane.¿ based on details available it could not be excluded that the reported event is user related and thus, it has to be classified as user-customer-decision errors.In case the item and / or substantive information will become available in future that suggests otherwise; the file will be reviewed.

• Brand Name: ADVANCED LOCKING SCREW IMN SCREWS 5X60MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 11750817
• Report Number: 0009610622-2021-00456
• Device Sequence Number: 14229262
• Product Code: HWC
• UDI-Device Identifier: 07613327381542
• UDI-Public: 07613327381542
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K130895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2021

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: Lay User/Patient
• Device Model Number: 2361-5060S
• Device Catalogue Number: 23615060S
• Device Lot Number: K01CFF2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/06/2021
• Supplement Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 04/29/2021
• Supplement Report FDA Received Date: 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1