MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW IMN SCREWS 5X90MM; SCREW, FIXATION, BONE

Model Number	2361-5090S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/20/2020
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.
Event or Problem Description
Surgeon had a case with a t2 alpha antegrade femoral nail where two of the distal transverse screws backed out approximately two weeks after surgery.Patient returned to operating room for surgical intervention.
Event or Problem Description
Surgeon had a case with a t2 alpha antegrade femoral nail where two of the distal transverse screws backed out approximately two weeks after surgery.Patient returned to or for surgical intervention.
Additional Manufacturer Narrative
The reported event was confirmed on provided x-ray.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 removed and disposed.Screw back out is a known but rare event and has been considered in several publications.Screw back out can be contributed by (but not limited to) e.G.Patient¿s condition, choice of product, kind of treatment, patient¿s behaviour and others.Based on available information it could not be determined which reasons had caused the event.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
Surgeon had a case with a t2 alpha antegrade femoral nail where two of the distal transverse screws backed out approximately two weeks after surgery.Patient returned to operating room for surgical intervention.
Additional Manufacturer Narrative
Please note corrections to sections d1, d4 (catalog number) and gtin number.

• Brand Name: LOCKING SCREW IMN SCREWS 5X90MM
• 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: 11020435
• Report Number: 0009610622-2020-00994
• Device Sequence Number: 19789004
• Product Code: HWC
• UDI-Device Identifier: 07613327381641
• UDI-Public: 07613327381641
• 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
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/19/2021

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: 10/31/2023
• Device Model Number: 2361-5090S
• Device Catalogue Number: 23605090S
• Device Lot Number: K04629E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/20/2020
• Supplement Date Received by Manufacturer: 02/08/2021; 04/27/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 03/04/2021; 05/19/2021
• 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