MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, TI, RIGHT GAMMA3® Ø11X420MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3225-0420S
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that one of the distal screws broken (most proximal), which dynamised the nail.Also broken gamma3 long nail was reported + pseudoarthrosis after almost 7 months.Surgeon left little piece of distal screw.Detection of broken distal screw at visit and x-ray after about 2 months.
Event or Problem Description
It was reported that one of the distal screws broken (most proximal), which dynamised the nail.Also broken gamma3 long nail was reported + pseudoarthrosis after almost 7 months.Surgeon left little piece of distal screw.Detection of broken distal screw at visit and x-ray after about 2 months.
Additional Manufacturer Narrative
The evaluation revealed both screw and broken nail to be primary products.No deviations were found during review of the manufacturing and inspection documents (dhr) for both units.No deficiency found during dimensional inspection of the returned products.The evaluation revealed that the nail broke in a fatigue fracture after a period of 7 months of implantation in a 27 year young male patient.According to found damages the fatigue fracture had its origination in the anterior web at lateral.In this area material damage had weekend the web caused by misaligned drilling with the step drill.The evaluation revealed that the screw broke in a fatigue fracture after a period of reported 2 months of implantation.The breakage had occurred in the smallest cross section of the screw.A fatigue fracture if the stresses on the implant are too high or not considerably reduced during the period of implantation.One requirement for successful nail treatment is a timely bone healing in order to relieve the implants over the progressing time of implantation.Potential adverse effects, e.G.Increased loading or material damage and impaired bone healing are clearly pointed out in the labeling.Based on the above screw breakage was determined 2 months after initial surgery.As no deficiency of the device was determined and from technical point of view early screw breakage is caused axial overload ¿ either, but not limited to, a gap in fracture reduction or exceeding weight bearing.The nail breakage was not linked to a deficiency of the device, but was mainly patient related (reported pseudarthrosis, impaired bone healing) contributed by intra operative material damage.Review of complaint history, capa databases and risk analysis did not identify any conspicuity.The review of the risk assessment for the failure mode indicated the issue was addressed adequately.There were no actions in place related to the reported event for the subject product.No nonconformity was identified.The event was not linked to a deficiency of the devices.

• Brand Name: LONG NAIL KIT R2.0, TI, RIGHT GAMMA3® Ø11X420MM 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
• MDR Report Key: 7102052
• Report Number: 0009610622-2017-00371
• Device Sequence Number: 1574672
• Product Code: HSB
• UDI-Device Identifier: 07613153312833
• UDI-Public: (01)07613153312833(11)170115(17)211231(10)K07A7521
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2018

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: 12/31/2021
• Device Model Number: 3225-0420S
• Device Catalogue Number: 32250420S
• Device Lot Number: K0A7521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2017
• Initial Date Received by Manufacturer: 11/15/2017
• Supplement Date Received by Manufacturer: 01/31/2018
• Initial Report FDA Received Date: 12/08/2017
• Supplement Report FDA Received Date: 02/23/2018
• 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: 29 YR
• Patient Weight: 65