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
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348); Implant Pain (4561)
Date of Event	06/01/2020
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 disposition is unknown.
Event or Problem 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 or Problem 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.".
Additional 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
• Common Device Name: 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
• Report Number: 0009610622-2020-00499
• Device Sequence Number: 1217480
• Product Code: HSB
• UDI-Device Identifier: 04546540375780
• UDI-Public: 04546540375780
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/31/2024
• Device Model Number: 3525-0440S
• Device Catalogue Number: 35250440S
• Device Lot Number: K0D7BE0
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/14/2020
• Supplement Date Received by Manufacturer: 10/22/2020
• Initial Report FDA Received Date: 09/08/2020
• Supplement Report FDA Received Date: 11/17/2020
• 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
• Patient Age: 58 YR
• Patient Weight: 152