MAUDE Adverse Event Report: STRYKER TRAUMA KIEL FEMORAL NAIL GT, LEFT T2 ALPHA FEMUR ANTEGRADE 11X440MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 2331-1144S

Device Problems Migration (4003); Separation Problem (4043)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 11/20/2020

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.

Event 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.

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 still implanted.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 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.

• Brand Name: FEMORAL NAIL GT, LEFT T2 ALPHA FEMUR ANTEGRADE 11X440MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 11020429
• MDR Text Key: 221798739
• Report Number: 0009610622-2020-00992
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07613327284270
• UDI-Public: 07613327284270
• Combination Product (y/n): N
• PMA/PMN Number: K191271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 2331-1144S
• Device Catalogue Number: 23311144S
• Device Lot Number: K08F57F
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention