MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 13X340MM X 125; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3425-3340S
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Iatrogenic Source (2498)
Date of Event	05/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event that long nail kit r1.5, ti, right gamma3® ø13x340mm x 125° was alleged of issue ¿user related event - not product related¿ could be confirmed with the help of information provided by the sales representative.A device inspection was not possible since the affected device was not returned, and no other evidences were provided for investigation.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.A review of the labeling did not indicate any abnormalities.Based on the investigation, the root cause of the failure is user related as the user inserted a right nail into a left femur which is an off-label use.It has also been stated in warning and precautions section in ifu as ¿4.2 intra-operative implants can be available in different versions, varying for example in length, diameter, angle, right-hand and left-hand versions, material and number of drilled holes.Select the required version carefully.¿ for the surgeon to choose the required version carefully.If the product is returned or any additional information is provided, the investigation will be reassessed.Device disposition is unknown.
Event or Problem Description
As reported: (b)(6) hospital was doing a gamma nail and inserted a right nail into a left femur.Due to the bow in the nail, the nail fractured the distal anterior cortex of the pt's femur busting out through the bone.Not knowing what caused this to occur, the surgeon opened a longer nail to try and by-pass this newly created fracture but this too was a right (wrong sided) nail and the same issue occurred with the nail going through the same distal anterior fracture.It was at this time they had realised the wrong sided nails were used both times.It was not long after this i arrived at the hospital.Surgical delay of approx 60 minutes.

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 13X340MM 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; DE D-24232
• MDR Report Key: 10176359
• Report Number: 0009610622-2020-00295
• Device Sequence Number: 2625453
• Product Code: HSB
• UDI-Device Identifier: 04546540406651
• UDI-Public: 04546540406651
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/19/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: 3425-3340S
• Device Catalogue Number: 34253340S
• Device Lot Number: K055C93
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2020
• Initial Report FDA Received Date: 06/19/2020
• 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: Other