MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3 10X440MM X 125; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 3525-0440S

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Injury (2348); Implant Pain (4561)

Event Date 06/01/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

As reported in medwatch (b)(4): "md's description of the incident: [left] gamma3 nail that broke through proximal screw aperture at 6 weeks.Nail was noted to be notched most likely most likely at time of insertion.Nail was found to be broken in x-ray 1.5 months later." patient was revised to another nail.

Event Description

As reported in medwatch (b)(4): "md's description of the incident: [left] gamma3 nail that broke through proximal screw aperture at 6 weeks.Nail was noted to be notched most likely most likely at time of insertion.Nail was.Found to be broken in x-ray 1.5 months later." patient was revised to another nail.Additionally reported: "patient was walking on memorial day, when he felt a sudden increase in pain in his left hip.".

Manufacturer Narrative

The reported event could be confirmed with the help of pictures provided.A device inspection was not possible since the affected device was not returned.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.The quality certificate of the heat number was reviewed.It corresponds to the material defined on the drawing and to the internal material specification.A review of the labeling did not indicate any abnormalities.The instructions for use states: ¿avoid surface damage of implants.Discard all damaged or mishandled implants.Contouring or bending of an implant should be avoided where possible, because it may reduce its fatigue strength and can cause failure under load.If contouring is necessary, allowed by design or prescribed by stryker, the physician should avoid sharp bending, reverse bending or bending the device at a screw hole.Such action must be performed with stryker instruments and in accordance with the specified procedures (see operative technique manual).¿ more detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.However, one of the possible causes of the breakage could be user related i.E.Handling failure (damage of implants during implantation either during drilling or lag screw insertion).If device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3 10X440MM X 125
• 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: 10504968
• MDR Text Key: 206091021
• Report Number: 0009610622-2020-00499
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540375780
• UDI-Public: 04546540375780
• Combination Product (y/n): N
• PMA/PMN Number: K034002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/17/2020

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
• Device Operator: Lay User/Patient
• Device Model Number: 3525-0440S
• Device Catalogue Number: 35250440S
• Device Lot Number: K0D7BE0
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/14/2020
• Initial Date FDA Received: 09/08/2020
• Supplement Dates Manufacturer Received: 10/22/2020
• Supplement Dates FDA Received: 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 152